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

Model Number DYNJP2004

Device Problems Hole In Material (1293); Product Quality Problem (1506)

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

Event Date 08/16/2017

Event Type  malfunction  

Event Description

This gown is poorly made.It is very thin and when you tie the gown you get holes where the ties are attached.

• Brand Name: MEDLINE
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6875266
• MDR Text Key: 86576026
• Report Number: 6875266
• 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: Patient
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DYNJP2004
• Device Catalogue Number: DYNJP2004
• Device Lot Number: 31117040013B
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2017
• Type of Device Usage: N
• Patient Sequence Number: 1