FDA Adverse Event
Death
Summary report: N
IPAS MVA PLUS
MDR report key: 1751267
·
Received July 7, 2010
Report
- Report Number
- 3008007615-2010-00005
- Event Type
- Death
- Date Received
- July 7, 2010
- Date of Event
- May 23, 2010
- Report Date
- July 8, 2010
- Manufacturer
- WOMANCARE GLOBAL
- Product Code
- HHI
- PMA / PMN Number
- PREAMENDM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT PERTAINS TO ONE EVENT THAT OCCURRED WITH THE USE OF THE PRODUCT DESCRIBED IN THIS REPORT CONNECTED TO THE PRODUCT DESCRIBED IN MANUFACTURER REPORT # 3008007615-2010-004.
Description of Event or Problem · 1
THE WOMAN CAME TO A CLINIC TO TERMINATE HER PREGNANCY. SHE WAS AT (B) (6) GESTATION UPON EXAMINATION. DURING THE PROCEDURE, SEVERE BLEEDING STARTED. A 10 IU OXYTOCIN GIVEN AND FLUID REPLACEMENT WAS DONE WITH A PINT OF RINGER LACTATE. BLEEDING STOPPED, THEN STARTED AGAIN. IN THE RECOVERY ROOM SHE WAS GIVEN 10 IU OXYTOCIN, AND FLUID REPLACEMENT WAS DONE WITH 1 PINT OF HAEMACCEL. SHE WAS THEN TAKEN TO A REFERRAL HOSPITAL 15 MINUTES AWAY. SHE DIED WITHIN 20 MINUTES IN THE REFERRAL HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IPAS MVA PLUS | HHI | WOMANCARE GLOBAL | PLUS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Death |