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

Catalog Number 11204

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

Patient Problem Skin Irritation (2076)

Event Date 07/15/2019

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 not number not known.Sample review not possible because no sample available.Trend data reviewed and no adverse trend observed.The root cause of the skin irritation is not known.

Event Description

It was reported that an end user had a colostomy performed for his neurogenic bowel.He was discharged home with nystatin powder and a competitor's skin prep to use under his appliance.He was not told he had a yeast or fungal skin infection.Within a week of surgery, he experienced blisters and red weepy skin under the ostomy appliance.He continues to use the nystatin powder and skin prep and he says his skin is improving.

• Brand Name: NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE CERAPLUS 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: 9076563
• MDR Text Key: 163300052
• Report Number: 1119193-2019-00037
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Weight: 91