MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GENERAL PACK; SURGICAL GOWN, STERILE PACK

Catalog Number DYNJ52563A

Device Problem Hole In Material (1293)

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

Event Date 03/16/2017

Event Type  malfunction  

Event Description

After the surgeon donned gown, he noticed holes in the gown.

• Brand Name: GENERAL PACK
• Type of Device: SURGICAL GOWN, STERILE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6503060
• MDR Text Key: 73120390
• Report Number: 6503060
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJ52563A
• Device Lot Number: 17BB3724
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Event Location: Other
• Date Report to Manufacturer: 04/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1