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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (NPOLF)367 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (NPOLF)367 GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number SNECNNPOLG
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2019
Event Type  Malfunction  
Manufacturer Narrative

The customer reported that the or towel (catalog# pwtb04-stm) in their neuro pack (catalog# snecnnpolg) appeared to be ¿linty¿ during a microdiscectomy. Manual removal and irrigation were needed which led to a ten minute delay in the procedure. No adverse effects to the patient are known at this time. The lot number was provided, and the supplier¿s review of the device history record did not indicate any exception that could lead to the reported incident. The average linting data is 0. 222g / 10 pieces. No sample was available for investigation, only a photo of the sample (with one loose thread) was provided. The supplier determined that is acceptable according to their sampling criteria. The or towel is made of cotton, so lint is inborn and inevitable. The measures used to control and improve linting include: a. Suctions machines are installed in the cloth rolling process, dyeing process and cutting process b. The suction process was added before the product's final folding, and workers do it according to standard operation procedure requirements. C. Linting test method and acceptable criteria are stipulated to see the suction results (=0. 38g/10 pieces). D. In the folding process, one cloth pad is under/protects 100 pieces semi-finished product to avoid lint sticking during product transfer. Based on the investigation, the root cause could not be determined and no action will be taken at this time the complaint information was shared with the relevant sectors for their awareness, and we will continue to monitor complaints for this type of incident.

 
Event Description

The customer reported that the or towel (catalog# pwtb04-stm) in their neuro pack (catalog# snecnnpolg) appeared to be ¿linty¿ during a microdiscectomy. Manual removal and irrigation were needed which led to a ten minute delay in the procedure. No adverse effects to the patient are known at this time.

 
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Brand NameNEURO PACK (NPOLF)367
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
1500 waukegan rd
waukegan, IL 60085
8478874151
MDR Report Key8823391
MDR Text Key164255571
Report Number1423537-2019-00336
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 CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSNECNNPOLG
Device LOT Number191685
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/15/2019
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: 07/24/2019 Patient Sequence Number: 1
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