OPSITE POST-OP VISIBLE 20X10CM CTN 20 66800138Recalls & reported problems
Smith & Nephew Medical Limited · Waterproof, bacteria proof dressing with absorbent see through pad · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223463106), received between Sep 8, 2021 and Sep 8, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient-Device Incompatibility1
Patient problems
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A STERILE WOUND DRESSING (OPSITE POST-OP VISIBLE) WAS APPLIED AFTER A HIP ARTHROPLASTY ON THE RIGHT THIGH. AT FOLLOW-UP 3 MONTHS POST-OP, A SHADING ON THE SKIN ACCORDING TO THE HONEYCOMB PATTERN OF THE DRESSING IS NOTICEABLE AND IT'S QUESTIONABLE IF THIS ADVERSE EVENT IS REVERSIBLE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Skin Discoloration
MAUDE report 12443093 ↗
Other Tape And Bandage, Adhesive devices
- IV3000-1-HAND 10X12CM-CARTON OF 50 66024008Smith & Nephew Medical Limited · Tape And Bandage, Adhesive62 reports
- CURAD NON25600QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall2 reports
- IV3000-1-HAND 6X7CM-CARTON OF 100 66024007Smith & Nephew Medical Limited · Tape And Bandage, Adhesive52 reports
- 3M™ 1500U3m Company · Tape and bandage, adhesive1 recall1 report
- CURAD NON25650QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall1 report
- CURAD NON256133QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- CURAD NON25660QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- Seer Home SM-01-9005Seer Medical Holdings Limited · Tape And Bandage, Adhesive1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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