MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for DORO? SKULL CLAMP RADIOLUCENT (3-PIN HFD) 4001-20 manufactured by Pro Med Instruments Gmbh.
| Report Number | 3003923584-2019-00030 |
| MDR Report Key | 9585946 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CHONA DELA CRUZ GARCIA |
| Manufacturer Street | BOETZINGER STR. 38 |
| Manufacturer City | FREIBURG, BADEN-WUERTTEMBERG 79111 |
| Manufacturer Country | GM |
| Manufacturer Postal | 79111 |
| Manufacturer G1 | PRO MED INSTRUMENTS GMBH |
| Manufacturer Street | BOETZINGER STR. 38 |
| Manufacturer City | FREIBURG, 79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 79111 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORO? SKULL CLAMP RADIOLUCENT (3-PIN HFD) |
| Generic Name | DORO? SKULL CLAMP RADIOLUCENT (3-PIN HFD) |
| Product Code | HBL |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2019-12-17 |
| Model Number | 4001-20 |
| Catalog Number | 4001-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRO MED INSTRUMENTS GMBH |
| Manufacturer Address | BOETZINGER STR. 38 FREIBURG, 79111 GM 79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |