MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT BARRIER EXTENDERS

Catalog Number 79402

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 09/15/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with (b)(4) 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 rash is not known.

Event Description

It was reported that an end user developed a skin rash under the product after using the hollister barrier extenders for 1 week.He was prescribed silvadene cream and it cleared up in 2 days.

• Brand Name: ADAPT BARRIER EXTENDERS
• Type of Device: ADAPT BARRIER EXTENDERS
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): EUROMED INC., A SCAPA HEALTHCARE COMPANY; 25 corporate drive; orangeburg NY 10962
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8476802170
• MDR Report Key: 9250814
• MDR Text Key: 179304835
• Report Number: 1064486-2019-00001
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 79402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• 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: 5 YR
• Patient Weight: 16