MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2011-03-21 for UNK manufactured by Unk.
[2214343]
Patient was reported to have presented at the clinic with complaints of chest pain, breathing problems, bleeding p/v and lower abdominal pain approximately 5 weeks after pregnancy termination which utilized manual vacuum aspiration method (mva). It was reported that mva was performed a total of 3 times at (b)(6). Dates of the procedures were not provided. The patient was referred to (b)(6) and subsequently expired. The date of the death was not reported. A team from (b)(6) was dispensed to gather pertinent information which indicated the patient died due to abortion complication. Further information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[9427223]
This case was identified after a national television broadcast was aired in (b)(6) and then reported to (b)(6) on (b)(6) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008007615-2011-00001 |
| MDR Report Key | 2287391 |
| Report Source | 00,01,05 |
| Date Received | 2011-03-21 |
| Date of Report | 2011-03-20 |
| Date of Event | 2010-12-04 |
| Date Added to Maude | 2011-10-13 |
| 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 | 0 |
| 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 | 7606359044 |
| Manufacturer G1 | PACIFIC HOSPITAL SUPPLY CO. |
| Manufacturer City | TONG, LO |
| Manufacturer Country | TW |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | MANUAL VACUUM ASPIRATOR AND CANNULA |
| Product Code | HHI |
| Date Received | 2011-03-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-03-21 |