MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX SKIN BARRIER WITH TAPE BORDER 44MM, 1 3/4 INCH PRE SIZED OPENIN

Catalog Number 14904

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

Patient Problem Swelling (2091)

Event Date 09/06/2018

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 was conducted and found to be complete and accurate.Sample review not possible because no sample available.Trend data reviewed and no adverse trend observed.

Event Description

It was reported that an end user experienced blisters under the tape border of the barrier.He was prescribed a steroid with antifungal cream, nystatin ointment, and fluocinonide ointment.The skin is no longer blistered.

• Brand Name: NEW IMAGE CONVEX SKIN BARRIER WITH TAPE BORDER 44MM, 1 3/4 INCH PRE SIZED OPENIN
• Type of Device: NEW IMAGE CONVEX 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: 8151001
• MDR Text Key: 130026020
• Report Number: 1119193-2018-00047
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14904
• Device Lot Number: 8I202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• 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: 64 YR
• Patient Weight: 95