FDA Adverse Event
Malfunction
Summary report: N
DORNIER COMPACT DELTA II LITHOTRIPTER
MDR report key: 2701816
·
Received August 1, 2012
Report
- Report Number
- 1037955-2012-00010
- Event Type
- Malfunction
- Date Received
- August 1, 2012
- Date of Event
- May 2, 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. DORNIER MEDTECH AMERICA INC. WAS NOTIFIED OF THIS INCIDENT ON (B)(4) 2012. THE HOSPITAL DID NOT NOTIFY DORNIER MEDTECH AMERICA, INC. OF THE INCIDENT AT THE TIME THE INCIDENT OCCURRED. THE LAST SERVICE CHECK OF THE DEVICE WAS ON (B)(6) 2012 AND SHOWED A PROPERLY WORKING DEVICE WITHIN SPECIFICATIONS. THE PATIENT HAS RECOVERED WITH NO PERMANENT INJURY. THE 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 |