MAUDE Adverse Event Report: PATIENTSTYLE MEDICAL LLC PATIENTSTYLE INFANT GOWN; GOWN, EXAMINATION

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

Metal snaps frequently break off/fall off, exposing sharp edges.

• Brand Name: PATIENTSTYLE INFANT GOWN
• Type of Device: GOWN, EXAMINATION
• Manufacturer (Section D): PATIENTSTYLE MEDICAL LLC; 2401 merced st ste 200; san leandro CA 94577
• MDR Report Key: 11581022
• MDR Text Key: 242702784
• Report Number: 11581022
• Device Sequence Number: 1
• Product Code: FME
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2021,03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1