MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER

Catalog Number 14804

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/15/2018

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 conducted based upon the lot number provided and found to be accurate and complete.Trend data reviewed and no adverse trend observed.

Event Description

It was reported that an end user developed a red rash under the tape border of the barrier about 2 months ago.A doctor prescribed nystatin powder in case it was a yeast infection and cephalexin in case it was a bacterial infection.It cleared up a little but is coming back.Since it is under the tape portion of the appliance, hollister customer service will send him tapeless samples to try.This rash has not expanded beyond the original area.

• Brand Name: NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE CONVEX FLEXTEND 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: 8090343
• MDR Text Key: 127930774
• Report Number: 1119193-2018-00042
• 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: 11/20/2018

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: 14804
• Device Lot Number: 5C212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2015
• 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: 74 YR
• Patient Weight: 107