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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
Model Number 89-10536.01
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  Malfunction  
Event Description

Deroyal pack was opened. Band around laps was broken. They were handed off and removed from room. Another pack of laps was opened. Patient was not in the room. Picture of deroyal pack sent to quality.

 
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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 Key11574401
MDR Text Key242407912
Report Number11574401
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 03/11/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-10536.01
Device Catalogue Number89-10536.01
Device LOT Number53119996
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2021
Event Location Hospital
Date Report TO Manufacturer03/26/2021
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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