MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-06 for ETHICON NYH 822-2005-03 * manufactured by Ethicon.
[199405]
Pneumo-veres needle failed to function properly. No pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 303760 |
| MDR Report Key | 303760 |
| Date Received | 2000-11-06 |
| Date of Report | 2000-11-04 |
| Date of Event | 2000-08-07 |
| Date Facility Aware | 2000-09-16 |
| Report Date | 2000-11-04 |
| Date Added to Maude | 2000-11-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON |
| Generic Name | NEEDLE |
| Product Code | FHO |
| Date Received | 2000-11-06 |
| Model Number | NYH 822-2005-03 |
| Catalog Number | * |
| Lot Number | CE0123 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 293974 |
| Manufacturer | ETHICON |
| Manufacturer Address | PO BOX 151 SUMMERVILLE NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-11-06 |