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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. LASE PACK GENERAL SURGERY TRAY

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DEROYAL INDUSTRIES, INC. LASE PACK GENERAL SURGERY TRAY Back to Search Results
Model Number 89-9686
Device Problems Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)
Patient Problem No Patient Involvement (2645)
Event Date 04/02/2018
Event Type  Malfunction  
Manufacturer Narrative

Investigation summary an internal complaint (call (b)(4)) was received for lase pack convenience tray (finished good 89-9686, lot 46579409). The report indicated that a scalpel broke through the packaging, resulting in an injury to a nurse. The defective sample was returned and confirmed that the scalpel blade was protruding from its sterile pouch. The bill of materials for the finished good tray was reviewed, and the scalpel contained within the tray was identified as raw material (b)(4), raw material lot 6261711. The work order was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The raw material is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request was issued to (b)(4). A response is due may 18, 2018, and as of the date of this report, a response has not been received. The scar and supplier notification letter logs were reviewed for similar complaints, and the investigator identified one previous scar for a similar issue. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.

 
Event Description

The scalpel was protruding from the packaging when the pack was opened. One of the nurses cut themselves on it.

 
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Brand NameLASE PACK
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 Key7473791
MDR Text Key107358007
Report Number3005011024-2018-00001
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-9686
Device LOT Number46579409
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/06/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2018
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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