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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVERTORS DE MEXICO, S.A. DE C.V. EP TRAY (EPHMD)105 GENERAL SURGERY TRAY (KIT)

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CONVERTORS DE MEXICO, S.A. DE C.V. EP TRAY (EPHMD)105 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SAN11EPHME
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Laceration(s) (1946)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative

Based on the customer information submitted, the staff member was cut by the halstead mosquito forcep sm161 that was sticking through the surgical pack on (b)(6) 2017. The staff member went to occupational medicine per hospital procedure and received a tetanus shot as a precautionary measure because he could not recall when he had had one last. All production process systems were reviewed and no discrepancies were found. This wo # (b)(4) was for (b)(4) kits and it was manufactured in lines (b)(6) and (b)(6) on (b)(6) 2017. (b)(4) kits were inspected by the production team with no defects found. (b)(4) kits were inspected by the qa team with no defects found. No rts or a/p for this component. The investigation was completed. The pack design of wo# (b)(4) was evaluated by the design team. The picture provided and the design of the kit were reviewed and we found a risk for the btc # (b)(4) to be punctured by the sharp component items # (b)(4), sm106 & sm161 since they are into a zip lock bag near to the btc. The kit was flagged for design change on (b)(6) 2017 to look for a safer placement for the sharp components and these components will be protected with soft components to avoid any damage to the btc.

 
Event Description

Based on the customer information submitted, the staff member was cut by the halstead mosquito forcep sm161 that was sticking through the surgical pack. The staff member went to occupational medicine per hospital procedure and received a tetanus shot as a precautionary measure because he could not recall when he had had one last.

 
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Brand NameEP TRAY (EPHMD)105
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
CONVERTORS DE MEXICO, S.A. DE C.V.
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer (Section G)
CONVERTORS DE MEXICO, S.A. DE C.V.
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer Contact
patricia tucker
1500 waukegan rd
waukegan, IL 60085
MDR Report Key7002862
MDR Text Key91085677
Report Number1423537-2017-00138
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 11/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSAN11EPHME
Device Catalogue NumberSAN11EPHME
Device LOT Number750378
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/18/2017
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/06/2017 Patient Sequence Number: 1
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