MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-12-21 for CONMED DISPOSABLE INSUFFLATION NEEDLE 60-6050-001 manufactured by Conmed Corporation.
[747980]
It was reported that "needle fell apart when being pulled out. None of the pieces were left in the patient. "
Patient Sequence No: 1, Text Type: D, B5
[7898299]
A supplemental report will be filed when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2007-00165 |
| MDR Report Key | 968669 |
| Report Source | 06,07 |
| Date Received | 2007-12-21 |
| Date of Report | 2007-12-20 |
| Date of Event | 2007-11-16 |
| Date Mfgr Received | 2007-11-20 |
| Date Added to Maude | 2008-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TYLER COREORAN |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED DISPOSABLE INSUFFLATION NEEDLE |
| Generic Name | DISPOSABLE INSUFFLATION NEEDLE |
| Product Code | FHO |
| Date Received | 2007-12-21 |
| Returned To Mfg | 2007-12-14 |
| Model Number | NA |
| Catalog Number | 60-6050-001 |
| Lot Number | 0703301 |
| ID Number | NA |
| Device Expiration Date | 2012-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 972820 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH RD. UTICA NY 13502 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-21 |