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

Model Number PROBABLE MVA PLUS

Device Problems Device Operates Differently Than Expected (2913); Extrusion (2934)

Patient Problems Death (1802); Pain (1994); Perforation (2001); Septic Shock (2068); Tissue Damage (2104); Bowel Perforation (2668)

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.

• Brand Name: IPAS MVA PLUS MANUAL VACUUM ASPIRATOR
• Type of Device: MVA 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 Key: 4289105
• MDR Text Key: 5268010
• Report Number: 3008007615-2014-00001
• Device Sequence Number: 1
• Product Code: HGH
• Combination Product (y/n): N
• Reporter Country Code: NP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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 Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PROBABLE 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 FDA: 11/24/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: NONE KNOWN AT THIS TIME.
• Patient Outcome(s): Death
• Patient Age: 35 YR