FDA Adverse Event
Injury
Summary report: N
DORO® QR3 SKULL CLAMP
MDR report key: 6953953
·
Received October 17, 2017
Report
- Report Number
- 3003923584-2017-00043
- Event Type
- Injury
- Date Received
- October 17, 2017
- Date of Event
- October 2, 2017
- Report Date
- October 2, 2017
- Manufacturer
- PRO MED INSTRUMENTS GMBH
- Product Code
- HBL
- UDI-DI
- 04250435506196
- PMA / PMN Number
- K001808
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CORRECTIVE ACTION NECESSARY, NO FAILURE ON THE DEVICE FOUND.
Description of Event or Problem · 1
PMI INC. CUSTOMER SERVICE INFORMED US ON (B)(6) ABOUT A DISTRIBUTOR STATING THE FOLLOWING: "THEY NOTIFIED US OF A PATIENT INCIDENT INVOLVING THE DORO QR3 EQUIPMENT. THEY WOULD LIKE TO HAVE THIS EQUIPMENT INSPECTED." ON THE SAME DAY, WE RECEIVED FURTHER INFORMATION FROM THE INITIAL REPORTER: "HEAD SLIPPAGE . THERE WERE FOUR MAYFIELD SKULL CLAMPS IN THE OR PLUS AN (PMI) QR 3. THEY ARE NOT SURE, IF THE MAYAFIELD CLAMPS CAUSED THE LACERATION OR THE QR 3 . MAYFIELDS WERE USED FIRST". INCIDENT DATE: (B)(6) 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734388 | DORO® QR3 SKULL CLAMP | DORO® QR3 SKULL CLAMP | HBL | PRO MED INSTRUMENTS GMBH | 1001.001 | 04250435506196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |