MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-11-25 for IPAS MVA PLUS MANUAL VACUUM ASPIRATOR PROBABLE MVA PLUS UNK manufactured by Womancare Global International.
[5268010]
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.
Patient Sequence No: 1, Text Type: D, B5
[12591500]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008007615-2014-00001 |
| MDR Report Key | 4289105 |
| Report Source | 01,05 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-10-30 |
| Date Reported to FDA | 2014-11-24 |
| Date Added to Maude | 2014-12-03 |
| 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 | KELLY CULWELL, MD |
| Manufacturer Phone | 6195501900 |
| Manufacturer G1 | PACIFIC HOSPITAL SUPPLY CO. |
| Manufacturer City | TANG, LO |
| Manufacturer Country | TW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPAS MVA PLUS MANUAL VACUUM ASPIRATOR |
| Generic Name | MVA PLUS |
| Product Code | HGH |
| Date Received | 2014-11-25 |
| Model Number | PROBABLE MVA PLUS |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| 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 INTERNATIONAL |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-11-25 |