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

Model Number DYNJ21971U

Device Problem Hole In Material (1293)

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

Event Date 01/18/2018

Event Type  malfunction  

Event Description

Scrubbed person was assisting the pa in donning her gown, scrubbed person noticed there was a small hole in the surgical gown.Gown was removed from person and removed from surgical field.

Manufacturer Narrative

The following elements have blank data.

Event Description

Scrubbed person was assisting the pa in donning her gown, scrubbed person noticed there was a small hole in the surgical gown.Gown was removed from person and removed from surgical field.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: SURGICAL GOWN, STERILE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7238074
• MDR Text Key: 98918236
• Report Number: 7238074
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ21971U
• Device Catalogue Number: DYNJ21971U
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1