1502M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-12-01 for 1502M manufactured by Cr Bard Inc.

Event Text Entries

[74760] Pt developed hydronephrosis after condom catheter was placed 2/20/97. Catheter was removed 2/24/97 after ultrasound revealed bilateral hydronephrosis cath had been checked for leakage and output had been recorded. There was no other documentation of care in pt's record. Pt transferred to tertiary ctr 2/25/97 where partial penectomy performed w/17 to days.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-1997-00059
MDR Report Key135593
Report Source05
Date Received1997-12-01
Date of Event1997-02-24
Date Mfgr Received1997-11-04
Date Added to Maude1997-12-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameMALE EXTERNAL CATHETER
Product CodeEXJ
Date Received1997-12-01
Model NumberNA
Catalog Number1502M
Lot NumberUNK
ID NumberUNK
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key125224
ManufacturerCR BARD INC
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Baseline Brand NameBARDIC URO-SHEATH
Baseline Generic NameMALE EXTERNAL CATHETER
Baseline Model NoNA
Baseline Catalog No1502M
Baseline IDNA
Baseline Device FamilyBARDIC URO-SHEATH
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK802433
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-12-01

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