MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE TWO-PIECE POUCHING SYSTEM; NEW IMAGE FLEXWEAR SKIN BARRIER WITH TAPE BORDER

Catalog Number 14203

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

Patient Problem Tissue Breakdown (2681)

Event Date 11/18/2019

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.Sample review not possible because no sample available.Trend data reviewed and no adverse trend observed.The root cause of the reported blisters under the skin barrier cannot be determined.

Event Description

It was reported that the end user experienced open blisters, extending beyond the edges of the barrier after using 7917 skin gel protective wipes along with this 14203 barrier.The end user was treated with oral prednisone, nystatin powder and neosporin.End user will be sent samples of another barrier product to try.

• Brand Name: NEW IMAGE TWO-PIECE POUCHING SYSTEM
• Type of Device: NEW IMAGE FLEXWEAR SKIN BARRIER WITH TAPE BORDER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 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. 60048-3781 ; 8476802170
• MDR Report Key: 9401991
• MDR Text Key: 168829439
• Report Number: 1119193-2019-00043
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• 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: 40 YR
• Patient Weight: 90