Dressing, Wound, Hydrogel Without Drug And/Or Biologic
FDA adverse event reports and recall history for dressing, wound, hydrogel without drug and/or biologic (product code NAE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 105
- Deaths
- 0
- Injuries
- 30
- Malfunctions
- 73
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-06-22TerminatedProcess control
Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief products to prevent potential contamination. .
- 2007-01-17TerminatedOther
HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.
Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
- TerminatedProcess control
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
The sterilization process used was unqualified.
- TerminatedProcess control
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
The sterilization process used was unqualified.
- Open, ClassifiedProcess control
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
- TerminatedOther
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Adhesive border was not sticky enough.
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