• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WOMANCARE GLOBAL INTERNATIONAL IPAS MVA PLUS MANUAL VACUUM ASPIRATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WOMANCARE GLOBAL INTERNATIONAL IPAS MVA PLUS MANUAL VACUUM ASPIRATOR Back to Search Results
Model Number PROBABLE MVA PLUS
Event Date 10/30/2014
Event Type  Death  
Event Description

This report will be followed by a supplemental report when the reporting physician goes to the sites and gleans more details. At a nepal facility, pt had a uterine aspiration at 10 weeks gestational age. After the procedure, the pt was discharged. She returned to the facility later that day experiencing pain. She was evaluated; there was concern that uterine perforation occurred during the procedure. Pt was sent to a hospital but there was a delay in laparotomy due to hospital issues and subsequently due to pt and family wishes. She had a laparotomy 3 days after the original mva; lap showed bowel injury and bowel reanastomosis performed. The pt seemed to be doing well but a week later the pt was doing worse. The family declined further treatment. Hospital wanted to refer the pt to a high -acuity hospital in (b)(6). Family instead took her to a hospital in (b)(6)). The hospital declined to treat the pt. Family and pt returned to the hospital in (b)(6), but "declined laparotomy". It is unclear whether the hospital "refused laparotomy" or the pt and/or her family refused a repeat laparotomy repair. The pt was referred to (b)(6). She was seen at a hospital in (b)(6). It is unclear what actually happened there. She was finally seen at a tertiary hospital in (b)(6). Stool was coming out of the laparotomy incision, the pt was septic and she died.

 
Manufacturer Narrative

Dr. (b)(6) is communicating with and may visit some of these treatment sites in (b)(6) to review records, obtain dates, and complete a more thorough report of the events leading to this death. Further information will be reported in a supplemental medwatch 3500a report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIPAS MVA PLUS MANUAL VACUUM ASPIRATOR
Type of DeviceMVA PLUS
Manufacturer (Section D)
WOMANCARE GLOBAL INTERNATIONAL
san diego CA
Manufacturer (Section G)
PACIFIC HOSPITAL SUPPLY CO.
tang, lo
TW 
Manufacturer Contact
kelly culwell, md
6195501900
MDR Report Key4289105
Report Number3008007615-2014-00001
Device Sequence Number1
Product CodeHGH
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPROBABLE MVA PLUS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/24/2014
Event Location Outpatient Treatment Facility
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/25/2014 Patient Sequence Number: 1
Treatment
NONE KNOWN AT THIS TIME.
-
-