MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-07-08 for NATURA DURAHESIVE MOLDABLE CONVEX WAFER 404592 manufactured by Convatec.
[18167039]
Stoma was plugged after 2 days enduser was to be afraid of this circumstance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00038 |
| MDR Report Key | 620209 |
| Report Source | 04 |
| Date Received | 2005-07-08 |
| Date of Report | 2005-07-08 |
| Date of Event | 2005-06-10 |
| Date Mfgr Received | 2005-06-10 |
| Date Added to Maude | 2005-07-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| 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 | NATURA DURAHESIVE MOLDABLE CONVEX WAFER |
| Generic Name | OSTOMY APPLIANCE |
| Product Code | EZS |
| Date Received | 2005-07-08 |
| Model Number | NA |
| Catalog Number | 404592 |
| Lot Number | 4D86334 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 609911 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX |
| Baseline Generic Name | OSTOMY WAFER |
| Baseline Model No | NA |
| Baseline Catalog No | 404592 |
| 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. Other | 2005-07-08 |