MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2010-07-07 for FLEXIBLE KARMAN CANNULAE FC4 manufactured by Womancare Global.
[15557700]
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.
Patient Sequence No: 1, Text Type: D, B5
[15848359]
Additional model numbers: fc5, fc6. Additional catalog numbers: fc5, fc6. 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 #3008007615-2010-005.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008007615-2010-00004 |
| MDR Report Key | 1751268 |
| Report Source | 01,05,07 |
| Date Received | 2010-07-07 |
| Date of Report | 2010-07-08 |
| Date of Event | 2010-05-23 |
| Date Mfgr Received | 2010-06-11 |
| Date Added to Maude | 2010-07-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 300 MARKET STREET SUITE 134 |
| Manufacturer City | CHAPEL HILL NC 27516 |
| Manufacturer Country | US |
| Manufacturer Postal | 27516 |
| Manufacturer Phone | 9194422621 |
| Manufacturer G1 | PACIFIC HOSPITAL SUPPLY CO. |
| Manufacturer City | TONG LO |
| Manufacturer Country | TW |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE KARMAN CANNULAE |
| Product Code | HGH |
| Date Received | 2010-07-07 |
| Model Number | FC4 |
| Catalog Number | FC4 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WOMANCARE GLOBAL |
| Manufacturer Address | CHAPEL HILL NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-07-07 |