MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER CONVEX FLEXTEND UROSTOMY POUCHING SYSTEM

Catalog Number 8485

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

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed for tape border or pouch film causing skin irritation or allergic reaction.Since lot number not provided dhr review not possible.Sample not returned so sample evaluation not possible.Root cause of reported irritation/rash under the film and tape border cannot be determined.

Event Description

It was reported that about 1 year ago an end user started experiencing an irritation/rash under the tape border of his ostomy appliance and under the pouch film that touches his skin.He reported that about 1 month ago he went to his doctor about the irritation and the doctor prescribed 0.1% triamcinolone acetonide cream.He said the doctor believes it to be an allergy.He further reported that the doctor did no more testing and the end user does not have a follow up appointment scheduled with the doctor.The end user continued to report that he is using this cream sparingly and it clears up the area but when he stops using it, the rash returns.End user is working with hollister customer service to try other hollister products to sample.

• Brand Name: PREMIER CONVEX FLEXTEND UROSTOMY POUCHING SYSTEM
• Type of Device: PREMIER CONVEX FLEXTEND UROSTOMY POUCHING SYSTEM
• 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: 13694364
• MDR Text Key: 286767982
• Report Number: 1119193-2022-00007
• 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
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8485
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/08/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 112 KG