• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL DEROYAL GENERAL SURGERY TRAY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEROYAL DEROYAL GENERAL SURGERY TRAY Back to Search Results
Model Number 89-10560.01
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  Malfunction  
Event Description

We opened up our laparotomy pack for emergent surgery and the patient was not in the room yet when we noticed in the large basin inside the laparotomy pack, a small tan brown object in the bowl that should not be there. We took pictures of it and quickly tore down the back table and contained it all within a trash bag and saved it and reopened a new pack after we took the old stuff out of the room. Once again patient was not in the room but the pack was a cmc laparotomy pack deroyal ref number (b)(4), lot number 5363491, expiration date 11-01-2022. Pack and contents not saved. Pictures taken of debris and packing list and are attached to this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEROYAL
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL
200 debusk lane
powell TN 37849
MDR Report Key11553331
MDR Text Key241794318
Report Number11553331
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 03/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/23/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-10560.01
Device Catalogue Number89-10560.01
Device LOT Number53634891
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2021
Event Location Hospital
Date Report TO Manufacturer03/23/2021
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

-
-