MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-24 for LUIKART-SIMPSON * manufactured by Allegiance/v.mueller.
[18163465]
In 2001, facility received a letter from allegiance healthcare in response to a report of bending forceps blades. The letter stated that the failure was related to a meterial used at the time of fabrication. Connunication with allegiance/v. Mueller in june 2003, found that luikart-simpson forceps manufactured prior to 1993 with lot numbers starting with the letters a through t, were manufactured with a softer alloy then the current devices. The softer alloy allowed the forceps to be bent out of specifications. All luikart-simpson ob forceps manufactured prior to 1993 were removed from the facilites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029117 |
| MDR Report Key | 474596 |
| Date Received | 2003-07-28 |
| Date of Report | 2003-07-24 |
| Date of Event | 2000-06-26 |
| Date Added to Maude | 2003-08-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUIKART-SIMPSON |
| Generic Name | OBSTETRICAL FORCEPS |
| Product Code | HCZ |
| Date Received | 2003-07-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | A THROUGH T |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 463458 |
| Manufacturer | ALLEGIANCE/V.MUELLER |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2003-07-28 |