MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-08-03 for DURAHESIVE FLEXIBLE NATURA WAFER * 125971 manufactured by Convatec.
[167639]
Pt noticed blood in ostomy pouch after applying durahesive flexible natura ostomy wafer. Pt went to hosp where dr put two dissolvable sutures into a small cut on the stoma. Dr counseled pt to cut larger holes in wafer before applyling to stoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2000-00005 |
| MDR Report Key | 288485 |
| Report Source | 05 |
| Date Received | 2000-08-03 |
| Date of Report | 2000-08-03 |
| Date Mfgr Received | 2000-07-26 |
| Date Added to Maude | 2000-08-08 |
| 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 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 100 HEADQUARTERS PARK DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAHESIVE FLEXIBLE NATURA WAFER |
| Generic Name | OSTOMY APPLIANCE 21 CFR 876.5900 |
| Product Code | EZS |
| Date Received | 2000-08-03 |
| Model Number | * |
| Catalog Number | 125971 |
| Lot Number | 0C23153 |
| ID Number | * |
| 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 | 279181 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 100 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US |
| Baseline Brand Name | DURAHESIVE FLEXIBLE NATURA WAFER |
| Baseline Generic Name | OSTOMY APPLIANCE |
| Baseline Model No | NA |
| Baseline Catalog No | 125971 |
| Baseline ID | NA |
| Baseline Device Family | TWO-PIECE OSTOMY APPLIANCE |
| Baseline Shelf Life Contained | N |
| 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 | 2000-08-03 |