FDA Adverse Event
Injury
Summary report: N
BACTISEAL EVD 1.9MM CATH SET
MDR report key: 5334853
·
Received December 30, 2015
Report
- Report Number
- 1226348-2015-10777
- Event Type
- Injury
- Date Received
- December 30, 2015
- Product Code
- JXG
- PMA / PMN Number
- PK021653
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION 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.
Description of Event or Problem · 1
TWO (2) EACH 82-1749 CATHETERS FAILED ALONG WITH 1 EACH EDS 3 DRAIN 82-1731. THE PATIENT GOT AN INFECTION WHILE USING OUR PRODUCT AND WOULD LIKE THE PRODUCTS REPLACED. THEY WERE DISCARDED BEFORE I COULD GET LOT NUMBERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857654 | BACTISEAL EVD 1.9MM CATH SET | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 82-1731 |