MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER

Catalog Number 14705

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

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

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

Lot number not known so dhr review is not possible.Sample not returned so sample evaluation not possible.End user stated that the issue was that the hollister product that worked well for her was not available for a time through her supplier.The product with which they substituted did not work well for her and allowed leakage.Once she was back in her original hollister product, the leakage resolved.

Event Description

It was reported that an end user who had been using hollister ostomy barriers for 25 years was recently sent a different hollister barrier by her supplier.The supplier said they did not have her preferred sku available.She used the different barrier but it allowed effluent leakage.The leakage eventually led to skin irritation on the bottom half of her peristomal skin.She needed medical treatment for the skin irritation in the form of prescription steroid cream.She has only been using the steroid cream for 2 days now so she is not sure if it is clearing up the skin irritation yet.In the meantime, the supplier had her preferred hollister barrier available again and supplied her with those two weeks ago.She is back to using her preferred hollister barrier and the leakage has now stopped.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER
• 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: 12359784
• MDR Text Key: 267874185
• Report Number: 1119193-2021-00028
• 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,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14705
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/17/2021
• 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: 55 YR
• Patient Weight: 86