FDA Adverse Event
Other
Summary report: N
404TT
MDR report key: 1625983
·
Received March 5, 2010
Report
- Report Number
- 1718873-2010-00001
- Event Type
- Other
- Date Received
- March 5, 2010
- Date of Event
- July 16, 2002
- Report Date
- February 23, 2010
- Manufacturer
- UTAH MEDICAL PRODUCTS, INC.
- Product Code
- HDB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UTMD IS FILING THIS REPORT AFTER BEING CONTACTED ON (B)(4) 2010 BY MALPRACTICE ATTORNEY, SEEKING VAD IFU EFFECTIVE ON (B)(4) 2002. PER THE MALPRACTICE ATTORNEY, THERE IS NO ALLEGATION THAT THERE WAS ANY DEFECT WITH THE VACUUM CUP. PRODUCT NOT RETURNED TO UTMD.
Description of Event or Problem · 1
ALLEGED INJURY: BRAIN BLEEDS DURING VAD DELIVERY, SURGERY WAS REQUIRED TO EXCAVATE THE BLOOD CLOTS, RESULTING IN A LONG TERM INJURY OF MOTOR AND COGNITIVE DEFICITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 404TT | VACUUM EXTRACTION CUP | HDB | UTAH MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Other |