MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BRIEF,CLOTHLIKE,FITEXTRA,XXL,60-69

Catalog Number	FITEXTRAXXL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after using the brief, the "material begins to crumble," the brief material went into the umbilicus, and the end-user experienced an infection.Despite multiple good faith attempts the end-user was unable or unwilling to provide additional information to the manufacturer.No details related to a specific diagnosis, medical treatment, and/or follow-up care are known.No sample has been returned to the manufacturer for evaluation and a root cause has been unable to be determined at this time.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the end-user experienced an infection during use of the brief product.
Additional Manufacturer Narrative
The end-user provided the manufacturer with additional information on 26-may-2021.Reportedly, the "inside absorbent part" of the brief was noted to be breaking down and entering the umbilicus.Although an infection was originally reported, the end-user indicated that she did not see a physician in relation to the incident and no information related to medical treatment has been reported.According to the end-user, samples of the brief are no longer available to be returned to the manufacturer for evaluation.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: BRIEF,CLOTHLIKE,FITEXTRA,XXL,60-69
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11760489
• Report Number: 1417592-2021-00087
• Device Sequence Number: 3237200
• Product Code: EYQ
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: FITEXTRAXXL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other