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 2010-06-24 for IPAS EASYGRIP CANNULAE UNK manufactured by Womancare Global.
[1635914]
A pregnant female of unknown age was told by a physician that the fetus was not alive. She contacted an ob/gyn who performed an exam and an ultrasound. He concluded that she was (b)(6) weeks pregnant; however, the fetus was not alive (missed abortion). The physician started performing a uterine evacuation procedure and suspected a perforation, so he stopped the procedure. The patient was experiencing mild lower abdomen pain. The following day she had developed a fever and was referred to another facility. No further information was obtained concerning the outcome.
Patient Sequence No: 1, Text Type: D, B5
[8624429]
Womancare global first became aware of this ae on 04/13/2010. Initially it was not clear if our cannulae was used or a competitor. On 05/22/2010, we received confirmation from dr (b)(6) that our device was involved.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3008007615-2010-00003 |
MDR Report Key | 1736789 |
Report Source | 01,05,07 |
Date Received | 2010-06-24 |
Date of Report | 2010-06-23 |
Date of Event | 2010-03-21 |
Date Mfgr Received | 2010-05-22 |
Date Added to Maude | 2010-06-29 |
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 | 3 |
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 | IPAS EASYGRIP CANNULAE |
Product Code | HGH |
Date Received | 2010-06-24 |
Model Number | UNK |
Catalog Number | UNK |
Lot Number | UNK |
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. Hospitalization | 2010-06-24 |