MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-03-24 for DORO? QR3 SKULL CLAMP 1001.001 manufactured by Pro Med Instruments Gmbh.
| Report Number | 3003923584-2020-00004 |
| MDR Report Key | 9870899 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2015-03-30 |
| Date Added to Maude | 2020-03-24 |
| 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 | MR. ERASMUS BAUMANN |
| Manufacturer Street | BOETZINGER STR. 38 |
| Manufacturer City | FREIBURG, 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORO? QR3 SKULL CLAMP |
| Generic Name | DORO? QR3 SKULL CLAMP |
| Product Code | HBL |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 1001.001 |
| Catalog Number | 1001.001 |
| 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 | 2020-03-24 |