Intrasite Gel Applipak 15g USA Ctn 10 66027311Recalls & reported problems
Smith & Nephew Medical Limited · Hydrogel Wound Dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00000050223480), received between Mar 9, 2022 and Oct 22, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 reports).
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
- Component Missing2
- Delivered as Unsterile Product2
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Impaired Healing1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT INTRASITE GEL APPLIPAK 15G CTN 10 WAS USED WITHOUT A PRESCRIPTION ON A PUNCTURED WOUND OF A DIABETIC PATIENT. THIS WOULD HAVE DETERIORATED THE WOUND AND LED TO THE AMPUTATION OF THE LEG. IT IS UNKNOWN WHAT THE CURRENT HEALTH STATUS OF PATIENT IS.
Patient problems: Impaired Healing; Insufficient Information
MAUDE report 15656339 ↗MalfunctionMar 9, 2022Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing
IT WAS REPORTED THAT, DURING TREATMENT, IT WAS OBSERVED THAT THE TUBE OF SOME INTRASITE GEL APPLIPAK 15G CTN 10 UNITS LACKED A CAP AND TUBE CLOSURE. IT WAS NOTED THAT THE CREAM WAS AIRBORNE AND THEREFORE NOT STERILE. THE NUMBER OF DEFECTIVE UNITS IS UNKNOWN. TREATMENT WAS COMPLETED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13715435 ↗MalfunctionMar 9, 2022Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing
IT WAS REPORTED THAT, DURING TREATMENT, IT WAS OBSERVED THAT THE TUBE OF SOME INTRASITE GEL APPLIPAK 15G CTN 10 UNITS LACKED A CAP AND TUBE CLOSURE. IT WAS NOTED THAT THE CREAM WAS AIRBORNE AND THEREFORE NOT STERILE. THE NUMBER OF DEFECTIVE UNITS IS UNKNOWN. TREATMENT WAS COMPLETED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13715192 ↗
Other Dressing, Wound, Hydrogel Without Drug And/Or Biologic devices
- DUODERM PASTE AND GELS 187987Convatec, Purchasing Department · Dressing, Wound, Hydrogel Without Drug And/Or Biologic24 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.
How reports and recalls are matched · Editorial policy · Report an error on this page