FDA Adverse Event
Summary report: N
CRANIAL ACCESS KIT
MDR report key: 1012598
·
Received March 7, 2008
Report
- Report Number
- 1226348-2008-00047
- Date Received
- March 7, 2008
- Manufacturer
- CODMAN & SHURTLEFF, INC/MEDOS S.A.
- Product Code
- GWM
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
Narratives
Additional Manufacturer Narrative · 1
IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AT THE MFG SITE. WITHOUT THE DEVICE IS IT NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MFG RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRANIAL ACCESS KIT | DEVICE, MONITORING, INTRACRANIAL PRESSURE | GWM | CODMAN & SHURTLEFF, INC/MEDOS S.A. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |