MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-11-11 for PILLING WECK * 507453 manufactured by Pilling Weck.
[112498]
It was reported that: tip of needle broke off from layngeal needle when physician was injecting. Both parts were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-1997-00008 |
| MDR Report Key | 131331 |
| Report Source | 05,06 |
| Date Received | 1997-11-11 |
| Date of Report | 1997-11-11 |
| Date of Event | 1997-03-24 |
| Report Date | 1997-11-11 |
| Date Added to Maude | 1997-11-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING WECK |
| Generic Name | ASPIRATING NEEDLE |
| Product Code | GDM |
| Date Received | 1997-11-11 |
| Model Number | * |
| Catalog Number | 507453 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 128369 |
| Manufacturer | PILLING WECK |
| Manufacturer Address | 1 WECK DR. PO BOX 12600 RESEARCH TRIANGLE PARK NC 27709 US |
| Baseline Brand Name | PILLINGWECK |
| Baseline Generic Name | ASPIRATING NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 507453 |
| Baseline ID | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1997-11-11 |