FDA Adverse Event
Injury
Summary report: N
EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
MDR report key: 3900585
·
Received June 27, 2014
Report
- Report Number
- 1226348-2014-11781
- Event Type
- Injury
- Date Received
- June 27, 2014
- Manufacturer
- CODMAN & SHURTLEFF
- Product Code
- JXG
- PMA / PMN Number
- PK954021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Additional Manufacturer Narrative · 1
NO SAMPLE WAS RETURNED FOR INVESTIGATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE PRODUCT CONFORMS TO SPECIFICATION WHEN RELEASED TO STOCK ON FEBRUARY 4TH, 2014. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.
Description of Event or Problem · 1
NO DRAINAGE BETWEEN THE DRIP CHAMBER AND THE COLLECTION BAG. INCIDENT NOT REPORTED TO THE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377352 | EXT DRAINAGE SYSTEM III WITHOUT VENT CATH | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF | CRBBKM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |