LAWRENCE SUPRAFOLEY - SUPRAPUBIC CATH AC851 IRU-516-856

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-12 for LAWRENCE SUPRAFOLEY - SUPRAPUBIC CATH AC851 IRU-516-856 manufactured by Teleflex - Rusch.

Event Text Entries

[2102458] Surgeon placed lawrence suprapubic catheter introducer, but was unable to thread a catheter. A piece broke of the outer sheath of the introducer causing the outer sheath to be "sucked" into the abdomen. The incision was extended to remove the sheath. Surgeon questions device problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5021323
MDR Report Key2163581
Date Received2011-07-12
Date of Report2011-06-29
Date of Event2011-06-28
Date Added to Maude2011-07-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLAWRENCE SUPRAFOLEY - SUPRAPUBIC CATH
Generic NameSUPRAPUBIC CATH INTRODUCER
Product CodeKOB
Date Received2011-07-12
Model NumberAC851 IRU-516-856
Lot Number24369
Device Expiration Date2014-02-01
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX - RUSCH


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2011-07-12

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