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 |