MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT FLAT BARRIER RING; ADAPT FLAT BARRIER RINGS 2"

Catalog Number 7805

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

Patient Problem Impaired Healing (2378)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

No sample received and no lot number provided.Without the sample or lot number hollister is unable to perform a full investigation regarding the skin issue.This will continue to be monitored in hollister's post marketed complaint system and actions will be taken if/when indicated.

Event Description

It was reported that end user used a piece of product to cover an open cut for 36 hours on her thumb.Days later, a callous formed in the area of the cut with a dark center.The dermatologist thinks the product irritated the skin and caused a reaction.The dermatologist scraped the lesion and sent it to the lab for culture.

• Brand Name: ADAPT FLAT BARRIER RING
• Type of Device: ADAPT FLAT BARRIER RINGS 2"
• 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: 8137291
• MDR Text Key: 129458971
• Report Number: 1119193-2018-00045
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 12/06/2018

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: 7805
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/06/2018
• 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: 70 YR
• Patient Weight: 48