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 |