MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BRIEF,FITRESTORE SUPER,XXL,60-70

Catalog Number FITRESTOREXXL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Rash (2033)

Event Date 12/10/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer, she used this product on her mother and she developed a "painful rash from them in the groin and vagina which required doctors prescription for nystatin powder cream and an oral prescription in the hospital".No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has been requested but not returned to manufacturer for evaluation.No additional information is available.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

Rash requiring prescription.

• Type of Device: BRIEF,FITRESTORE SUPER,XXL,60-70
• 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: 16102489
• MDR Text Key: 306701928
• Report Number: 1417592-2023-00016
• Device Sequence Number: 1
• Product Code: EYQ
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: FITRESTOREXXL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2022
• 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