MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-08-01 for INSUFFLATION/ACCESS NEEDLE 14 GAUGE * S100000 manufactured by Ponce - Uss.
[503690]
Procedure: lap cholecystectomy. Reportedly, after inserting the access needle into the cavity, the needle cover could not return to the proper position. The blade remained exposed. Another device was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2006-00328 |
| MDR Report Key | 760710 |
| Report Source | 01,05 |
| Date Received | 2006-08-01 |
| Date of Report | 2006-07-14 |
| Date of Event | 2006-07-13 |
| Date Mfgr Received | 2006-07-14 |
| Date Added to Maude | 2006-09-18 |
| 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 | JEFF DEMING - QA |
| Manufacturer Street | 195 MCDERMOTT RD. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926049 |
| Manufacturer G1 | PONCE - USS |
| Manufacturer Street | SABANETAS INDUSTRIAL PARK |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSUFFLATION/ACCESS NEEDLE 14 GAUGE |
| Generic Name | DISPOSABLE SURGICAL ACCESS DEVICE |
| Product Code | FHO |
| Date Received | 2006-08-01 |
| Model Number | * |
| Catalog Number | S100000 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 748628 |
| Manufacturer | PONCE - USS |
| Manufacturer Address | SABANETAS INDUSTRIAL PARK MERCEDITA PR 00715 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-01 |