MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER

Catalog Number 11203

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

Patient Problem Abrasion (1689)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

End user did not save device or other devices from that lot of product.End user does not have the ability to take photos on his phone to provide to the manufacturer for review.Dhr review conducted and no issues identified.Trend data reviewed and no adverse trend observed.Root cause of this reported issue cannot be determined but the user cutting the barrier stoma opening bigger seems to be helping.Weight not provided so estimation used.

Event Description

It was reported that the end user had his colostomy surgery on (b)(6) 2020.Since then, he has experienced 3-4 stoma bleeds while using the new image ostomy barrier.The bleeding is coming from cuts that he describes as little nicks on the stoma.He states that he cuts the cut-to-fit barrier very carefully and makes sure there are no sharp edges.He reports that his stoma moves in and out a little.The first bleed was while he was still in the hospital 2 days after surgery.He is usually able to stop the bleeding himself by applying pressure.One time, on (b)(6) 2020, the stoma had cuts and would not stop bleeding.He went to the er where they used chemical cautery (silver nitrate) to stop the bleeding.He is now cutting the barrier stoma opening larger and has stopped taking baby aspirin.Since then, he said it is doing much better.He will be visiting the (b)(6) soon.

• Brand Name: NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville, il
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft, va
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., ; 6802170
• MDR Report Key: 9981971
• MDR Text Key: 188415396
• Report Number: 1119193-2020-00007
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2020

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: 11203
• Device Lot Number: 0C092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 04/21/2020
• 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 Age: 57 YR
• Patient Weight: 91