MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2005-07-11 for INSUFFLATION/ACCESS NEEDLE 14 GAUGE S100000 manufactured by Ponce-uss.
[19058434]
The system jammed and insufflation of the patient cavity was not possible. Therefore, a new device was used to complete the procedure without further incident. Procedure: unk. Patient status: no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2005-00388 |
| MDR Report Key | 686440 |
| Report Source | 01,05,06,07 |
| Date Received | 2005-07-11 |
| Date of Report | 2005-03-09 |
| Date of Event | 2005-03-09 |
| Date Mfgr Received | 2005-03-09 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2006-03-15 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | 2005-07-11 |
| Returned To Mfg | 2005-06-02 |
| Model Number | NA |
| Catalog Number | S100000 |
| Lot Number | P4B1057 |
| ID Number | NA |
| Device Expiration Date | 2009-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 675655 |
| 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 | 2005-07-11 |