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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL GENERAL SURGERY TRAY

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DEROYAL INDUSTRIES, INC. DEROYAL GENERAL SURGERY TRAY Back to Search Results
Catalog Number 89-10560.01
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 04/19/2021
Event Type  Malfunction  
Event Description

After patient had been brought into the operating room, scrub tech found a hair in her asepto bulb syringe, between the flange of the bulb and the syringe. This is the asepto that was included in the laparotomy pack opened for the case. The attending surgeon was notified and the entire set up was broken down and a new set up with all new instruments and supplies was opened. Picked up by (b)(6) rep.

 
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Brand NameDEROYAL
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
200 debusk lane
powell TN 37849
MDR Report Key11769067
MDR Text Key248878853
Report Number11769067
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/20/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-10560.01
Device LOT Number54011549
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/22/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2021
Event Location Hospital
Date Report TO Manufacturer05/04/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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