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 |