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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. KEESLER ARTHROGRAM TRAY GENERAL SURGERY TRAY

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DEROYAL INDUSTRIES, INC. KEESLER ARTHROGRAM TRAY GENERAL SURGERY TRAY Back to Search Results
Model Number 89-8813
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 11/07/2018
Event Type  Malfunction  
Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating that a deroyal convenience kit (part number 89-8813, lot 48323378) contained a lidocaine bottle that did not appear to be effective, resulting in the patient experiencing pain. The physician ultimately pulled an additional bottle of lidocaine to complete the procedure. The end user reported the expiration date on the lidocaine bottle contained within the pack to be april 1, 2020. A sample was returned for evaluation november 21. The complaint investigator was unable to review the work order for the reported lot. The work order was not scanned digitally into deroyal's (b)(4), and the hard copy could not be located either. (b)(4). During an inventory inspection, the investigator found one bottle of the same raw material part and raw material lot number. This bottle was pulled from stock and placed in quarantine. The 2016-present supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar issues. No similar issues were found, but due to the nature of the reported event, a scar was issued to (b)(4). The supplier also was notified that the defective sample was returned. As of the date of this report, a scar response has not been received. (b)(4) has acknowledged receipt of the complaint. Deroyal will continue to monitor post market feedback and will recognize in the future if the issue reoccurs. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.

 
Event Description

"a" arthrogram kit contained lidocaine that did not seem effective. A patient reportedly experienced pain as a result, and the doctor injected additional medication that did not seem to work. This resulted in the physician pulling an additional bottle of lidocaine, which was effective.

 
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Brand NameKEESLER ARTHROGRAM TRAY
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette TN 37766
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette TN 37766
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key8138083
MDR Text Key130472613
Report Number3005011024-2018-00014
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK842648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-8813
Device LOT Number48323378
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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