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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 89-10581.01
Device Problems Contamination (1120); Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  Malfunction  
Event Description

On opening for the morning case, the scrub observed reddish brown stains on wrapper of suction tubing and also on and in actual suction tubing. Saved - tubing, packing list sheet for deroyal vascular pack. Pictures taken and sent to quality. Did not delay the case, patient had not been brought back to the operating room yet. Suction tubing and packing list save for quality. (b)(4).

 
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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 Key11640667
MDR Text Key244630521
Report Number11640667
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 03/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-10581.01
Device LOT Number53450021
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/23/2021
Event Location Hospital
Date Report TO Manufacturer04/09/2021
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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