MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for DORO? QR3 SKULL CLAMP 1001.001 manufactured by Pro Med Instruments Gmbh.
[177383534]
The moveable arm of the device did not slide properly. Due to this deviation, it cannot be excluded that the device has contributed to the event. It is likely that improper care and maintenance and/or reprocessing has led to the deviation.
Patient Sequence No: 1, Text Type: N, H10
[177383535]
Customer service was contacted on (b)(6) 2020 by customer. Customer stated that the surgeon was unable to fully release the skull clamp from the patient's head. This resulted the pin scratching the patient's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003923584-2020-00001 |
| MDR Report Key | 9652568 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| 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 | 2020-01-31 |
| Returned To Mfg | 2020-01-15 |
| 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 | 2020-01-31 |