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

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 7805
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/29/2018
• 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 Treatment Data

Date Received: 12/06/2018 Patient Sequence Number: 1