FDA Adverse Event
Injury
Summary report: N
MITY VAC
MDR report key: 1131543
·
Received August 14, 2008
Report
- Report Number
- 1216677-2008-00028
- Event Type
- Injury
- Date Received
- August 14, 2008
- Date of Event
- July 29, 2008
- Report Date
- August 14, 2008
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- HDB
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 0
REPORT DOES NOT DEFINITELY IDENTIFY THE MITY VAC USED, EITHER THE TWO-PIECE (PUMP AND EXTRACTOR CUP) OR THE ONE-PIECE (MYSTICII). IN EITHER CASE, THE OPERATIONAL GUIDELINES INDICATES A SUBGALEAL HEMORRHAGE IS A POSSIBLE FETAL ADVERSE EVENT. THE OPERATIONAL GUIDELINES ALSO INSTRUCTS TO EXAMINE THE FETAL HEAD FOR TRAUMA FOLLOWING A POP-OFF. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 0 | MITY VAC | VACUUM ASSIST DELIVERY | HDB | COOPERSURGICAL, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | Required Intervention |