MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING

Catalog Number 14709

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

Patient Problem Skin Irritation (2076)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review not possible because lot number not known.Samples not available so review not possible.End user's weight not available so an estimation was used in this report.The root cause of the reported skin irritation cannot be determined.

Event Description

It was reported that an end user experienced a rash with small areas of sores, blisters and bleeding under the barrier portion of the ostomy appliance.The end user was prescribed topical steroids, hydrogel and a dressing for the area.The end user's wocn stated there was nothing wrong with the ostomy barrier and that her skin is just sensitive.The areas are now healing in response to the treatment.

• Brand Name: NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING
• Type of Device: NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING
• 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: 9341071
• MDR Text Key: 167126293
• Report Number: 1119193-2019-00041
• 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: 11/19/2019

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: 14709
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/19/2019
• 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: 65 YR
• Patient Weight: 57