FDA Adverse Event
Injury
Summary report: N
HEALTH TRONICS LITHOTRON
MDR report key: 549823
·
Received August 2, 2004
Report
- Report Number
- MW1032892
- Event Type
- Injury
- Date Received
- August 2, 2004
- Date of Event
- May 7, 2004
- Report Date
- August 2, 2004
- Manufacturer
- HMT
- Product Code
- LNS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LITHOTRIPSY TREATMENT PERFORMED WHERE POST TREATMENT PT REQUIRED HOSPITALIZATION FOR TRANSFUSION. TREATING PHYSICIAN FEELS PT IS NOT GETTING ESSENTIAL VITAMINS, NUTRIENTS NEEDED FOR PROPER BLOOD CLOTTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEALTH TRONICS LITHOTRON | LITHOTRIPTER | LNS | HMT | LSH161 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| L |