N/A DIAGNOSTIC ULTRASOUND CATHETER, 8F 10439011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for N/A DIAGNOSTIC ULTRASOUND CATHETER, 8F 10439011 manufactured by Sterilmed, Inc..

Event Text Entries

[141178915] Poor image. We have been working with the reps for those issues. Those are reprocessed catheters. The reps have been trying to trouble shoot and tried several things. So far no answers yet. This catheter was approved by fda for reprocessing. That is why we are asking to report because it might be something at the reprocess center.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8490930
MDR Report Key8490930
Date Received2019-04-08
Date of Report2019-03-26
Date of Event2019-02-21
Report Date2019-03-26
Date Reported to FDA2019-03-26
Date Reported to Mfgr2019-04-08
Date Added to Maude2019-04-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A DIAGNOSTIC ULTRASOUND CATHETER, 8F
Generic NameREPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
Product CodeOWQ
Date Received2019-04-08
Catalog Number10439011
Lot Number2084323
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTERILMED, INC.
Manufacturer Address5010 CHESHIRE PKWY N STE 2 PLYMOUTH MN 55446 US 55446


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-08

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