MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for IPAS MANUAL VACUUM ASPIRATION (MVA); IPAS EASY GRIP CANNULAE PLUS manufactured by Womancare Global.
[74472950]
Device was not made available.
Patient Sequence No: 1, Text Type: N, H10
[74472951]
Womancare global was notified by an (b)(6) user site of the ipas manual vacuum aspirator (mva) and ipas easy grip cannulae that a serious adverse event occurred on (b)(6) 2015. The (b)(6) health professional communicated that a patient had an uterine aspiration procedure at 8 weeks gestational age under a paracervical block. At the end of the procedure, a uterine perforation had occurred. The woman was to undergo a tubal ligation as a contraceptive method. Direct visualization of the fundal perforation was performed. Though there was no bleeding from the perforation site, a stitch was secured by a gynecologist during the tubal ligation procedure. The patient did not require hospitalization. The patient was reported to be stable and doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008007615-2016-00001 |
| MDR Report Key | 6546387 |
| Date Received | 2017-05-04 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2015-12-22 |
| Date Added to Maude | 2017-05-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. KELLY CULWELL |
| Manufacturer Street | 12400 HIGH BLUFF DRIVE SUITE 600 |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8583144025 |
| Manufacturer G1 | PACIFIC HOSPITAL SUPPLY CO., LTD |
| Manufacturer Street | NO. 19, TZI-CHIANG ROAD TOMG-LO INDUSTRIAL DISTRICT |
| Manufacturer City | MIAOLI, MIAOLI 366 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 366 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IPAS MANUAL VACUUM ASPIRATION (MVA); IPAS EASY GRIP CANNULAE |
| Generic Name | VACUUM ABORTION SYSTEM; CANNULA-SUCTION, UTERINE |
| Product Code | HHI |
| Date Received | 2017-05-04 |
| Model Number | PLUS |
| Catalog Number | PLUS |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WOMANCARE GLOBAL |
| Manufacturer Address | 12400 HIGH BLUFF DRIVE SUITE 600 SAN DIEGO CA 92130 US 92130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-04 |