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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CMC LAPAROTOMY PACK; GENERAL SURGERY TRAY (KIT)

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DEROYAL INDUSTRIES, INC. CMC LAPAROTOMY PACK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number 89-10560
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2022
Event Type  malfunction  
Manufacturer Narrative
A user facility medwatch report (#4900240000-2022-8083) reporting rip in outer blue wrap of pack.Pack removed from room.New pack obtained.A sample was provided to deroyal for evaluation.Root cause: was identified as due to no tray protector being under the basin.Corrective action: quality control specialist contacted tray engineering to evaluate the tray and to add a tray protector under the basin.Engineering change order number 57616 has been created to add a tray protector under the basin.Production records were reviewed, and no issues were found.An inventory check of the back table cover was made by deroyal, a total of 50 of the 5-11976 back table covers were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
 
Event Description
Rip in outer blue wrap of pack.Pack removed from room.New pack obtained.
 
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Brand Name
CMC LAPAROTOMY PACK
Type of Device
GENERAL SURGERY TRAY (KIT)
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
melissa logsdon
200 debusk lane
powell, TN 37849
8653626157
MDR Report Key15276677
MDR Text Key305168103
Report Number3005011024-2022-00031
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00749756363778
UDI-Public00749756363778
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K842648
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 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number89-10560
Device Catalogue Number89-10560
Device Lot Number56779199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2022
Initial Date FDA Received08/23/2022
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
Patient Sequence Number1
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