MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE INDUSTRIES, INC.; DRESSING,CONTACT LAYER,VERSATEL ONE,4X7NAD

Model Number MSC1847EP

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, the dressing "created abrasion and disrupted graft due to shifting on male genitalia".No additional information was provided by the customer.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Disrupted graft site.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: DRESSING,CONTACT LAYER,VERSATEL ONE,4X7NAD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17174844
• MDR Text Key: 317641162
• Report Number: 1417592-2023-00258
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 10888277113817
• UDI-Public: 10888277113817
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MSC1847EP
• Device Catalogue Number: MSC1847EP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other