MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-05-30 for INSUFFLATION/ACCESS NEEDLE 14 GAUGE * S100000 manufactured by Ponce - Uss.
[469961]
Procedure: oopherocystectomy. When the package was opened the blunt stylet was observed to be retracted and the needle was exposed. The surgeon proceeded to insert it into the cavity but the stylet would not advance. However, the cavity had been penetrated which cause a small amoutn of tissue damage which resulted in bleeding of less than 100cc. The surgeon used electrocautery to stop the bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2006-00235 |
| MDR Report Key | 721463 |
| Report Source | 01,05 |
| Date Received | 2006-05-30 |
| Date of Report | 2006-05-09 |
| Date of Event | 2006-05-08 |
| Date Mfgr Received | 2006-05-09 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-06-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JEFF DEMING |
| 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 | 2006-05-30 |
| Model Number | * |
| Catalog Number | S100000 |
| Lot Number | P6A753 |
| ID Number | * |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 710531 |
| Manufacturer | PONCE - USS |
| Manufacturer Address | SABANETAS INDUSTRIAL PARK MERCEDITA PR 00715 US |
| Baseline Brand Name | INSUFFLATION/ACCESS NEEDLE 14G |
| Baseline Generic Name | SURGICAL ACCESS NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | S100000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-30 |