FDA Adverse Event
Malfunction
Summary report: N
DORNIER COMPACT DELTA LITHOTRIPTER
MDR report key: 5356975
·
Received January 11, 2016
Report
- Report Number
- 1037955-2015-00033
- Event Type
- Malfunction
- Date Received
- January 11, 2016
- Date of Event
- December 15, 2015
- Report Date
- December 15, 2015
- Manufacturer
- DORNIER MEDTECH SYSTEMS GMBH
- Product Code
- LNS
- PMA / PMN Number
- P840008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A SERVICE REPORT COMPLETED 12/15/2015 INDICATED THAT THE DEVICE WAS IN COMPLIANCE WITH DORNIER SPECIFICATIONS. A HEMATOMA IS LISTED AS A POTENTIAL ADVERSE EFFECT AND COMPLICATION IN THE COMPACT DELTA OPERATING MANUAL. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT. NO FAULT WITH THE DEVICE AS MANUFACTURED. DEVICE WAS FOUND TO BE FUNCTIONING WITHIN DORNIER SPECIFICATIONS. DORNIER MEDTECH AMERICA, INC. (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (THE MANUFACTURER) PER EXEMPTION NUMBER E2012002.
Description of Event or Problem · 0
PATIENT HEMATOMA REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15725 | DORNIER COMPACT DELTA LITHOTRIPTER | LITHOTRIPTER | LNS | DORNIER MEDTECH SYSTEMS GMBH | COMPACT DELTA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |