MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-06-18 for LUMEN FINDER DEVICE #1 * 50-7875 manufactured by Pilling Surgical.
[387939]
The tip of the lumen finder was reported to have detached from the stem of the lumen finder during use. The tip was able to be retrieved and no injuries or medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515651-2004-00002 |
| MDR Report Key | 598640 |
| Report Source | 06 |
| Date Received | 2004-06-18 |
| Date of Report | 2004-05-21 |
| Date Mfgr Received | 2004-05-21 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2005-05-05 |
| 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 | 3 |
| Manufacturer Contact | BRADLEY SEIDEN, MANAGER |
| Manufacturer Street | 200 PRECISION RD SUITE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2154428892 |
| Manufacturer G1 | PILLING SURGICAL |
| Manufacturer Street | 200 PRECISION RD SUITE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMEN FINDER DEVICE #1 |
| Generic Name | PROBE |
| Product Code | FGM |
| Date Received | 2004-06-18 |
| Returned To Mfg | 2004-06-03 |
| Model Number | * |
| Catalog Number | 50-7875 |
| Lot Number | WW2 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 588468 |
| Manufacturer | PILLING SURGICAL |
| Manufacturer Address | 200 PRECISION RD. SUITE 200 HORSHAM PA 19044 US |
| Baseline Brand Name | LUMEN FINDER |
| Baseline Generic Name | PROBE |
| Baseline Model No | 50-7875 |
| Baseline Catalog No | 50-7875 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-18 |