MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND BARRIER WITH TAPE BORDER; OSTOMY POUCHING SYSTEM

Model Number 14606

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

The root cause of this reported event is most likley due to the end user's diagnosed chronic skin condition presentiing with recurrent abscesses, scarring and sinus tract formation and not with the use of the hollister ostomy barrier.There was no evidence of a device malfunction.

Event Description

It was reported that the user developed skin lesions under the tape portion of the new image flextend barrier.He has been diagnosed with hidradenitis suppurativa which results in skin lesions which develop as a result of inflammation and infection of the sweat glands.One of the lesions under the tape portion of the barrier was the size of a quarter and began draining pus and blood.He was hospitalized (b)(6) 2017 and received iv antibiotics.He is currently using a silver dressing over the lesion and under the barrier.The lesions are healing.

• Brand Name: NEW IMAGE FLEXTEND BARRIER WITH TAPE BORDER
• 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: 7227866
• MDR Text Key: 98575960
• Report Number: 1119193-2018-00006
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,literature
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2018,01/30/2018

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 Model Number: 14606
• Device Catalogue Number: 14606
• 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: 01/05/2018
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/30/2018
• 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: 29 YR
• Patient Weight: 88