MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CONVERTORS; GOWN, SURGICAL

Model Number 39049

Device Problems Material Puncture/Hole (1504); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

The physician's gown was noted to be misaligned at the seams creating holes in the sterile gown.Operation room team members covered it with a tegaderm and kept working.The integrity of paper gowns is being called into question with multiple issues and recalls.

• Brand Name: CONVERTORS
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 9882725
• MDR Text Key: 185050835
• Report Number: 9882725
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380108693
• UDI-Public: (01)10885380108693
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 39049
• Device Catalogue Number: 39049
• Device Lot Number: 19KBD502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1