MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER FLEXTEND UROSTOMY POUCH WITH CONVEX BARRIER AND TAPE BORDER

Catalog Number 8485

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.User does not know the lot number and does not have any samples to return so dhr review and sample evaluation is not possible.Trend data reviewed and no adverse trend observed.

Event Description

It was reported that an end user developed skin irritation and blistering under the tape portion of his ostomy barrier beginning in the middle of (b)(6) 2018.Due to itching and scratching, the blisters would break open.The rash did not resolve using over the counter products so he obtained the services of a nurse practitioner.He was prescribed a steroid liquid to be used on his skin under the tape at each appliance change.He is seeing some improvement.

• Brand Name: PREMIER FLEXTEND UROSTOMY POUCH WITH CONVEX BARRIER AND TAPE BORDER
• Type of Device: PREMIER FLEXTEND UROSTOMY POUCH WITH CONVEX BARRIER AND TAPE BORDER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 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. 60048-3781 ; 8476802170
• MDR Report Key: 7494975
• MDR Text Key: 107630352
• Report Number: 1119193-2018-00020
• 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: Patient
• Type of Report: Initial
• Report Date: 05/03/2018

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Weight: 74