MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2000-04-01 for NI * manufactured by Convatec.
[180460]
Pt experienced eczema under adhesive collar of ostomy wafer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2000-00003 |
| MDR Report Key | 272123 |
| Report Source | 01,04 |
| Date Received | 2000-04-01 |
| Date of Report | 2000-03-31 |
| Date of Event | 1999-12-01 |
| Date Added to Maude | 2000-04-05 |
| 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 | NI |
| Generic Name | 876.5900 OSTOMY APPLIANCE & ACCESSORY |
| Product Code | EXD |
| Date Received | 2000-04-01 |
| Returned To Mfg | 2000-01-14 |
| Model Number | * |
| Catalog Number | NI |
| Lot Number | 9016746, 9B14360 |
| ID Number | * |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 263436 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 100 HEADQUARTERS PARK DR SILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-01 |