FDA Adverse Event
Malfunction
Summary report: N
DORNIER COMPACT DELTA II LITHOTRIPTER
MDR report key: 2701818
·
Received August 1, 2012
Report
- Report Number
- 1037955-2012-00012
- Event Type
- Malfunction
- Date Received
- August 1, 2012
- Date of Event
- June 16, 2012
- Report Date
- August 1, 2012
- Manufacturer
- DORNIER MEDTECH SYSTEMS GMBH
- Product Code
- LNS
- PMA / PMN Number
- P8400008
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS (B)(4) (THE MANUFACTURER PER EXEMPTION (B)(4)).
Description of Event or Problem · 1
A HEMATOMA WAS NOTICED ON PATIENT. A SERVICE CHECK WAS COMPLETED ON (B)(4) 2012. THE SERVICE CHECK SHOWED A PROPERLY WORKING DEVICE BEING IN ITS DEFINED SPECIFICATIONS. DORNIER MEDTECH AMERICA, INC. WAS NOTIFIED OF THIS INCIDENT ON (B)(6) 2012. DORNIER MEDTECH AMERICA, INC. WAS NOT NOTIFIED AT THE TIME THE INCIDENT OCCURRED. THE PATIENT HAS RECOVERED WITH NO PERMANENT DAMAGE OR DISABILITY. INCIDENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DORNIER COMPACT DELTA II LITHOTRIPTER | LITHOTRIPTER | LNS | DORNIER MEDTECH SYSTEMS GMBH | COMPACT DELTA II |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |