STOMAHESIVE PASTE 183910

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 1999-05-18 for STOMAHESIVE PASTE 183910 manufactured by Convatec.

Event Text Entries

[131355] Registered nurse enterostomal therapist (rnet) applied stomahesvie paste around a ureterostomy and applied a sur-fit stomahesvie wafer and pouch over the stoma. After 8-10 hrs, the pt's caregiver (daughter) noticed no urine in the pouch and brought the pt to the hosp, where a catheterization yielded 350 cc of urine. Catheter removed (reason unknown) and pt given percutaneous nephrostomy. Ureterostomy soon after became and pt discharged home.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1049092-1999-00002
MDR Report Key223995
Report Source05
Date Received1999-05-18
Date of Report1999-04-21
Date of Event1999-02-25
Date Mfgr Received1999-04-21
Date Added to Maude1999-05-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSTOMAHESIVE PASTE
Generic NameSKIN BARRIER
Product CodeEZS
Date Received1999-05-18
Model NumberNA
Catalog Number183910
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key217207
ManufacturerCONVATEC
Manufacturer Address100 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US
Baseline Brand NameSTOMAHESIVE PASTE
Baseline Generic NameOSTOMY ACCESSORY
Baseline Model NoNA
Baseline Catalog No183910
Baseline IDNA
Baseline Device FamilyOSTOMY POUCH AND ACCESSORIES
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]60
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1999-05-18

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