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.
[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
Report Number | 1049092-1999-00002 |
MDR Report Key | 223995 |
Report Source | 05 |
Date Received | 1999-05-18 |
Date of Report | 1999-04-21 |
Date of Event | 1999-02-25 |
Date Mfgr Received | 1999-04-21 |
Date Added to Maude | 1999-05-21 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | STOMAHESIVE PASTE |
Generic Name | SKIN BARRIER |
Product Code | EZS |
Date Received | 1999-05-18 |
Model Number | NA |
Catalog Number | 183910 |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 217207 |
Manufacturer | CONVATEC |
Manufacturer Address | 100 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
Baseline Brand Name | STOMAHESIVE PASTE |
Baseline Generic Name | OSTOMY ACCESSORY |
Baseline Model No | NA |
Baseline Catalog No | 183910 |
Baseline ID | NA |
Baseline Device Family | OSTOMY POUCH AND ACCESSORIES |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 60 |
Baseline PMA Flag | N |
Baseline 510K PMN | N |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | Y |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1999-05-18 |