OPSITE™ FLEXIGRID 4631,66024631Recalls & reported problems
Smith & Nephew Medical Limited · Transparent dressing 15cm x 20cm, Carton of 10 Transparent dressing 6in x 8in, Carton of 10 · Class 1
Data updated Oct 16, 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 05000223415433), received between Dec 17, 2020 and Dec 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 16, 2026.
Most reported problems
Device problems
- Loss of or Failure to Bond1
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 17, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS ADMITTED TO HOSPITAL FOR PANCREATITIS. AFTER OPERATION, A DRESSING WAS GIVEN TO PROTECT THE WOUND. ABOUT 30 MINUTES LATER, THE PATIENT COMPLAINED THAT DRESSING DID NOT STICK TO THE SKIN. THE DOCTOR OBSERVED THAT THE DRESSING WAS NOT ADHESIVE ENOUGH TO KEEP THE WOUND CLOSED, WHICH INCREASED THE PROBABILITY OF INFECTION. DISINFECTION, REPLACEMENT AND GAUZE FIXATION WERE GIVEN. NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11031700 ↗
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
- CURAD NON25650QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall1 report
- 3M™ 1500U3m Company · Tape and bandage, adhesive1 recall1 report
- Lucky Super Soft Bandages in differenet sizeDelta Brands Inc. · Tape And Bandage, Adhesive1 recall0 reports
- 3M™ Durapore™ 1538-1183M Deutschland GmbH · Tape and bandage, adhesive1 recall0 reports
- CURAD NON256133QSMedline Industries, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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