FDA Adverse Event
Death
Summary report: N
MITY VAC
MDR report key: 929214
·
Received October 17, 2007
Report
- Report Number
- 1216677-2007-00027
- Event Type
- Death
- Date Received
- October 17, 2007
- Date of Event
- September 22, 2007
- Report Date
- October 17, 2007
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- HDB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORT FAXED INTO COOPERSURGICAL WAS LACKING DETAILS. THE USER FACILITY HAS BEEN CONTACTED. THE USER FACILITY INDICATED AN INVESTIGATION WAS UNDERWAY AND WOULD FORWARD ADDITIONAL INFORMATION. SCALP TRAUMA, SKULL FRACTURE AND HEMORRHAGE ARE AMONG THE FETAL INJURIES LISTED ON THE OPERATIONAL GUIDELINES FOR THE EXTRACTOR CUP. AS OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. WHEN THE REQUESTED ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED AS APPROPRIATE. ADD'L MODEL NUMBER: 10004. ADD'L LOT NUMBER: 51454.
Description of Event or Problem · 1
UNEXPECTED FETAL DEATH DURING DELIVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MITY VAC | VACUUM ASSIST DELIVERY | HDB | COOPERSURGICAL, INC. | 10007 | 46742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |