Opsite Post-Op Visible 15x10cm Ctn 20 66800137Recalls & 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 05000223463076), received between Dec 9, 2021 and Dec 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2021Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT, THE PACKAGING OF A OPSITE POST-OP VISIBLE 15 X 10 CTN 20 IS NOT CLOSED PROPERLY SO THAT THE DRESSING IS NO LONGER STERILE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A THERAPEUTIC ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12972485 ↗
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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