MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for LUIKART-SIMPSON OBSTETRICAL FORCEPS 46-5050 manufactured by Fetzer Medical Gmbh & Co. Kg.
[131474528]
It was reported by the healthcare professional to the company who initiated the initial mdr that the doctors were unable to pull the obstetrical forceps apart and that they were able to remove the forceps after several minutes. No patient was harmed, the malfunction was detected prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007648354-2018-00001 |
| MDR Report Key | 8189078 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2017-03-27 |
| Date Added to Maude | 2018-12-21 |
| 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 | MS DANIELA KAUFMANN |
| Manufacturer Street | UNTER BUCHSTEIG 5 |
| Manufacturer City | TUTTLINGEN, BADEN-WUERTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | FETZER MEDICAL GMBH & CO. KG |
| Manufacturer Street | UNTER BUCHSTEIG 5 |
| Manufacturer City | TUTTLINGEN, BADEN-WUERTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LUIKART-SIMPSON OBSTETRICAL FORCEPS |
| Generic Name | OBSTETRICAL FORCEPS |
| Product Code | HDA |
| Date Received | 2018-12-21 |
| Model Number | 46-5050 |
| Lot Number | 17302220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FETZER MEDICAL GMBH & CO. KG |
| Manufacturer Address | UNTER BUCHSTEIG 5 TUTTLINGEN, BADEN-WUERTTEMBER 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |