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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 89-10552
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  Malfunction  
Event Description

Hair was found attached to plastic lid in deroyal cmc extremity pack, ref (b)(4), lot number 52886018, exp 03-01-2022; hair was found during unpacking; in was contained and we did not need to tear down entire sterile field.

 
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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 Key10934271
MDR Text Key219147324
Report Number10934271
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 11/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-10552
Device Catalogue Number89-10552
Device LOT Number52886018
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2020
Event Location Hospital
Date Report TO Manufacturer12/02/2020
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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