MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2010-05-26 for IPAS EASYGRIP CANNULAE SR4 manufactured by Womancare Global.
[1559196]
The pt underwent a uterine evacuation procedure on (b) (6) 2010. She developed fever and abdominal pain on (b) (6) 2010. She was taken to a referral hospital on (b) (6) 2010. She died on (b) (6) 2010. The diagnosis was septic shock.
Patient Sequence No: 1, Text Type: D, B5
[8554663]
Add'l model#: sr5, catalog#: sr5. This ae report pertains to one event that occurred with the use of the product described in this report connected to the product described in mfr report # 3008007615-2010-00001. The ipas easy grip cannulae is connected to the ipas mva plus aspirator to perform uterine evacuation procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008007615-2010-00002 |
| MDR Report Key | 1700938 |
| Report Source | 00,01 |
| Date Received | 2010-05-26 |
| Date of Report | 2010-05-26 |
| Date of Event | 2010-03-09 |
| Date Mfgr Received | 2010-04-27 |
| Date Added to Maude | 2010-06-01 |
| 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 | 2010-05-26 |
| Model Number | SR4 |
| Catalog Number | SR4 |
| 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. Death | 2010-05-26 |