MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER SOFT CONVEX TAPE BORDERED POUCH

Catalog Number 8678

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 02/17/2022

Event Type  Injury  

Event Description

It was reported that an end user started developing a skin rash with weepiness under the tape border of his hollister ostomy appliance.He reported that he has had his stoma for 6 years and had been using this appliance the whole time.He reported that this skin rash started 2-3 months ago and has had a skin biopsy, been on oral prednisone, topical hydrocortisone, and received kenalog & consentyx injections to treat this and none of it has worked.He is now calling hollister for suggestions.Hollister will send him samples of products without tape borders for him to try.

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Device history records reviewed for the lot number provided and found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported reaction to the tape border of the ostomy appliance cannot be determined.

• Brand Name: PREMIER SOFT CONVEX TAPE BORDERED POUCH
• Type of Device: PREMIER SOFT CONVEX TAPE BORDERED POUCH
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 14490174
• MDR Text Key: 294778466
• Report Number: 1119193-2022-00018
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8678
• Device Lot Number: 2C072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male