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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 89-10561.01
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  Malfunction  
Event Description

Approximately 7in long hair discovered in cmc laparoscopy pack under the drape included in the pack (very bottom of pack). Entire set up broken down and all new sterile pack, supplies and instruments opened prior to patient being brought into room. Pack nor item(s) with hair was saved; no pictures taken; packing list saved.

 
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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 Key11752237
MDR Text Key248179885
Report Number11752237
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 04/14/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-10561.01
Device LOT Number54011602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/14/2021
Event Location Hospital
Date Report TO Manufacturer04/30/2021
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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