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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE IR NEURO PACK 629 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE IR NEURO PACK 629 NEUROLOGICAL TRAY Back to Search Results
Model Number SAN44IRUTA
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2020
Event Type  Malfunction  
Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation. A follow-up report will be filed once the results have been completed.

 
Event Description

Customer reported that the blue, sterile, cotton or towels pwtb04-stm, from the ir neuro pack san44iruta/lot 375598 are shedding fibers onto various wires and catheters during a intracranial embolization. The towels were used for fluid absorption outside the drape. There was no injury or delay. No patient demographics were provided after attempts. Cardinal health is proactively filing a report for malfunction.

 
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Brand NameIR NEURO PACK 629
Type of DeviceNEUROLOGICAL TRAY
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 Key10102513
MDR Text Key194351757
Report Number1423537-2020-00462
Device Sequence Number1
Product Code OJG
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,Followup
Report Date 06/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSAN44IRUTA
Device Catalogue NumberSAN44IRUTA
Device LOT Number375598
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/14/2020
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: 05/29/2020 Patient Sequence Number: 1
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