MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER

Catalog Number 14902

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

Patient Problem Skin Irritation (2076)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

Trend data reviewed and no adverse trend observed.Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review could not be conducted because the lot number is not known.Sample review not possible because no sample available.The root cause of the skin irritation cannot be determined.

Event Description

It was reported that an end user has been experiencing red, bumpy, irritated skin under the tape and barrier portion of the hollister ostomy appliance for the past 2 years.Six months ago she started using clobetasol propionate topical solution on the irritated areas.It clears it up but when she stops using the solution, the irritated skin returns.She has been referred to the hollister customer service group so she can trial other products.

• Brand Name: NEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER
• Type of Device: NEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER
• 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: 10333348
• MDR Text Key: 205160558
• Report Number: 1119193-2020-00020
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2020

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: 14902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 57