MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-19 for VERESS NEEDLE * manufactured by Core Dynamics.
[211347]
During laparoscopic tubal ligation the right common iliac artery was punctured and the common iliac vein was torn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 367276 |
| MDR Report Key | 367276 |
| Date Received | 2001-12-19 |
| Date of Report | 2001-02-02 |
| Date of Event | 2001-01-19 |
| Date Facility Aware | 2001-01-19 |
| Report Date | 2001-02-02 |
| Date Reported to Mfgr | 2001-02-02 |
| Date Added to Maude | 2001-12-26 |
| 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 | VERESS NEEDLE |
| Generic Name | DISPOSABLE INSUFFLATION NEEDLE |
| Product Code | FHO |
| Date Received | 2001-12-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 0J837CT |
| ID Number | PART NUMBER A007.00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 356399 |
| Manufacturer | CORE DYNAMICS |
| Manufacturer Address | 11222 ST. JOHNS INDUST PARKWAY JACKSONVILLE FL 32246 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2001-12-19 |