FDA Adverse Event
Summary report: N
MAYFIELD
MDR report key: 441774
·
Received February 3, 2003
Report
- Report Number
- 1525725-2003-00003
- Date Received
- February 3, 2003
- Manufacturer
- OHIO MEDICAL INSTRUMENT CO., INC.
- Product Code
- HBL
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
(OMI) BECAME AWARE OF A POSSIBLE PT INJURY (LACERATION). AT THIS TIME, USER DID NOT HAVE DETAILS OF THE EVENT, BUT DID ACKNOWLEDGE THAT THERE MAY HAVE BEEN AN INCIDENT INVOLVING AN OMI MAYFIELD A2000 SKULL CLAMP. MFR FAXED USER A COPY OF OMI'S "PT EVENT FORM WITH INJURY" WITH A REQUEST TO HAVE THE FORM FILLED OUT WITH INFO PERTAINING TO THE ABOVE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD | SKULL CLAMP | HBL | OHIO MEDICAL INSTRUMENT CO., INC. | 4-0-A-2000 | 007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |