MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER FLEXTEND BARRIER WITH TAPE AND LOCK N ROLL CLOSURE; OSTOMY POUCHING SYSTEM

Model Number 8331

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

There was no evidence of a device malfunction.There is no trend observed for this sku and complaint type.

Event Description

It was reported that the end user developed irritation on (b)(6) 2018.The area is red, irritated and bleeds easily.On (b)(6) 2018 she sought medical treatment and was prescribed oral antibiotics and clotrimazole and bethamethazone ditropionate.She is beginning to see a little improvement.

• Brand Name: PREMIER FLEXTEND BARRIER WITH TAPE AND LOCK N ROLL CLOSURE
• Type of Device: OSTOMY POUCHING SYSTEM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60068
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 7413228
• MDR Text Key: 104913550
• Report Number: 1119193-2018-00014
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/16/2018,04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8331
• Device Catalogue Number: 8331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Report to Manufacturer: 03/16/2018
• Date Manufacturer Received: 03/16/2018
• 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: 76 YR
• Patient Weight: 57