ACTIVELIFE 022771Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00768455101610), received between Jun 21, 2019 and May 13, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2022Sharp Edges; Sharp Edges

  THE END USER REPORTED THAT THE TAIL CLOSURE FELT ROUGH AND SURMISED THAT THERE HAD BEEN A CHANGE IN THE CLIP CLOSURES THAT WAS SNAGGING THE POUCH FILM. THEY WERE MUCH MORE DIFFICULT TO OPEN AND CLOSE THAN THEY USED TO BE AND THE FORCE NEEDED TO OPEN AND CLOSE MIGHT PERHAPS CONTRIBUTING TO THE ISSUE. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14390048 ↗
• MalfunctionMay 13, 2022Sharp Edges; Sharp Edges

  THE END USER REPORTED THAT THE TAIL CLOSURE FELT ROUGH AND SURMISED THAT THERE HAD BEEN A CHANGE IN THE CLIP CLOSURES THAT WAS SNAGGING THE POUCH FILM. THEY WERE MUCH MORE DIFFICULT TO OPEN AND CLOSE THAN THEY USED TO BE AND THE FORCE NEEDED TO OPEN AND CLOSE MIGHT PERHAPS CONTRIBUTING TO THE ISSUE. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14390047 ↗
• InjuryMar 23, 2022Device Handling Problem; Device Handling Problem

  THE END USER PROVIDED VERY LIMITED INFORMATION AND REPORTED THAT THIS WAS AN ONGOING ISSUE FOR YEARS AND COULD NOT PROVIDE DATE OF ONSET. SHE ALSO STATED THAT SHE WAS A MULTI-PRODUCT USER AS SHE HAD A KNOWN DIAGNOSED ALLERGY TO ADHESIVES AND DID NOT GET GOOD RESULTS WITH NON-ADHESIVE SYSTEM. SHE NOW DISCONTINUED THE USE OF COMPANY'S PRODUCT AND ALTERNATED WITH OTHER MANUFACTURERS WHICH SEEMED TO KEEP HER SKIN IN CHECK. HOWEVER, WHEN SHE DID NOT ROTATE, HER SKIN APPEARED RED WITH BLISTERS, WEEPING, ITCHING AND A FUNGAL OVERGROWTH FOR WHICH SHE REQUIRED ANTIBIOTICS AND ANTI-FUNGAL. SHE ALSO STATED THAT THIS HAD OCCURRED UNDER BOTH THE MASS AND TAPE COLLAR ON THE PRODUCT. SHE DECLINED TO PROVIDE ADDITIONAL INFORMATION SUCH AS THE NAME OF THE MEDICATIONS, THE TIME WHEN SHE NEEDED A MEDICATION FOR USE OF THE CONVATEC PRODUCT AND DECLINED TO PROVIDE THE PHOTOS ALSO.

  Patient problems: Blister; Erythema; Fungal Infection; Itching Sensation; Tissue Breakdown

  MAUDE report 13868597 ↗
• MalfunctionOct 13, 2021Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Discomfort; Laceration(s); Pain; Tissue Breakdown

  MAUDE report 12622471 ↗
• MalfunctionJun 21, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN THREE WAFERS WHICH REDUCED WEAR TIME. NO PHOTO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723516 ↗
• MalfunctionJun 21, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN THREE WAFERS WHICH REDUCED WEAR TIME. NO PHOTO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723513 ↗
• MalfunctionJun 21, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN THREE WAFERS WHICH REDUCED WEAR TIME. NO PHOTO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723511 ↗