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

Model Number 39079

Device Problem Material Puncture/Hole (1504)

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

Event Date 03/12/2020

Event Type  malfunction  

Event Description

Surgical smartgown was donned in preparation for surgery.After arms were in the gown and before picking up gloves, a large hole was found along a seem on the left sleeve near the wrist.The gown was removed and saved for evaluation.

• 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: 10244585
• MDR Text Key: 197940710
• Report Number: 10244585
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380038235
• UDI-Public: (01)10885380038235
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 39079
• Device Catalogue Number: 39079
• Device Lot Number: 19KCC042
• 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: 06/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1