MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT

Model Number 14204

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

Patient Problem Skin Irritation (2076)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Lot number not provided so dhr review is not possible.Sample not returned so a sample evaluation is not possible.Trend data reviewed and no adverse trend observed.End user's weight not provided so estimation used.The root cause of the skin irritation cannot be determined.

Event Description

It was reported that an end user developed a rash under and beyond part of the tape area of the hollister ostomy barrier.His doctor prescribed topical cream containing clortrimazole and betamethasone.The cream is wiped off before applying the barrier in order to allow the barrier and tape to adhere.The rash has not cleared up yet so he will be seeing a medical professional again.

• Brand Name: NEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT
• Type of Device: NEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT
• 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, il ; 3602170
• MDR Report Key: 10272037
• MDR Text Key: 198753028
• Report Number: 1119193-2020-00015
• 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: Other
• Type of Report: Initial
• Report Date: 07/14/2020

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 Model Number: 14204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/14/2020
• 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: 58 YR
• Patient Weight: 84