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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT,OPEN HEART CON (HCOA )933 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE KIT,OPEN HEART CON (HCOA )933 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number PVCGOHCOB
Device Problem Material Frayed (1262)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2020
Event Type  Malfunction  
Manufacturer Narrative

From the device history record, lot number 190430100sh was manufactured from 13th mar to 18th mar 2019. No exception was recorded in the device history record that could lead to the reported incident. Sample not sent to plant due to covid-19, only photos were provided. Supplier observed that the x-ray filament in the photos looks very straight, while the x-ray filament in their actual product is twisted. Therefore, supplier confirmed that the sample in the photos does not belong to them. Supplier checked the operation of workers, and they are within compliance with the standard of operation (sop) of gauze swab production. Therefore, the root cause could not be determined. There is no action taken at this time, however, we will continue to monitor the trend of this type of incident.

 
Event Description

Based on information received by the customer, the raytec sponges in the custom pack are reportedly fraying and the sponges cannot be used.

 
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Brand NameKIT,OPEN HEART CON (HCOA )933
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer (Section G)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key10861492
MDR Text Key218246531
Report Number1423537-2020-00562
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 COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 11/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberPVCGOHCOB
Device Catalogue NumberPVCGOHCOB
Device LOT Number468450
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/15/2020
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/18/2020 Patient Sequence Number: 1
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