FDA Adverse Event
Death
Summary report: N
MITY VAC
MDR report key: 1408866
·
Received June 23, 2009
Report
- Report Number
- 1216677-2009-00018
- Event Type
- Death
- Date Received
- June 23, 2009
- Date of Event
- January 29, 2009
- Report Date
- June 23, 2009
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- HDB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
IN SPEAKING WITH THE INITIAL REPORTER, NO DEVICE MALFUNCTION OCCURRED, AND NO PRODUCT DEFECTS WERE NOTED. THE DEVICE FUNCTIONED AS DESIGNED.
Description of Event or Problem · 1
DELIVERY OF A TERM INFANT WITH A KNOWN CRANIUM MALFORMATION USED A VACUUM ASSISTANCE FOR DELIVERY. THERE WERE NO POP-OFF'S. TIME USAGE WAS LESS THAN 20 MINUTES. AFTER DELIVERY, THE INFANT WAS TRANSPORTED TO NICU WHERE THE INFANT LATER EXPIRED, FOLLOWING INTENSE RESUSCITATIVE ACTIONS. A POST-MORTEM SHOWED GROSS CRANIAL HEMORRHAGE, BOTH SUBDURAL AND SUBARACHNOID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MITY VAC | VACUUM ASSIST DELIVERY | HDB | COOPERSURGICAL, INC. | 10007LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |