MAUDE Adverse Event Report: AMD MEDICOM INC. AMD RITMED ASSUREWEAR VERSAGOWN; GOWN, ISOLATION, SURGICAL

Model Number A69982

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

It was reported that gown, isolation, white, xla user facility reported that the gown gave a nurse a rash.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMD RITMED ASSUREWEAR VERSAGOWN
• Type of Device: GOWN, ISOLATION, SURGICAL
• Manufacturer (Section D): AMD MEDICOM INC.
• MDR Report Key: 17692706
• MDR Text Key: 322834555
• Report Number: MW5145240
• Device Sequence Number: 1
• Product Code: FYC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: A69982
• Patient Sequence Number: 1