MAUDE Adverse Event Report: DYNAREX CORPORATION SURGICAL GOWNS; GOWN, SURGICAL

Model Number 8193

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

Event Type  malfunction  

Event Description

Narrative from staff: during setup the certified surgical technologist (cst) assigned to the case gowned using our disposable surgical gown.After gowning the staff in the room noticed a dead fly on the floor right where the cst gowned.This fly was not there at the start of the day and it is believed that this fly was in the surgical gown that had been opened.The cst removed the gown and rescrubbed.

• Brand Name: SURGICAL GOWNS
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): DYNAREX CORPORATION; 10 glenshaw st; orangeburg NY 10962
• MDR Report Key: 12655757
• MDR Text Key: 277153562
• Report Number: 12655757
• Device Sequence Number: 1
• Product Code: FYA
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8193
• Device Lot Number: 47776
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 79