FDA Adverse Event
Injury
Summary report: N
DORNIER COMPACT DELTA II
MDR report key: 6971037
·
Received October 24, 2017
Report
- Report Number
- 1037955-2017-00050
- Event Type
- Injury
- Date Received
- October 24, 2017
- Report Date
- October 10, 2017
- Manufacturer
- DORNIER MEDTECH SYSTEMS GMBH
- Product Code
- LNS
- PMA / PMN Number
- P840008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A SERVICE REPORT COMPLETED AND DATED 10/10/2017 BY A DMTA FIELD SERVICE ENGINEER 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 II OPERATING MANUAL. THE DETAILS CONCERNING INDIVIDUAL PATIENT OUTCOMES ARE UNKNOWN. 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 |
|---|---|---|---|---|---|---|---|
| 754820 | DORNIER COMPACT DELTA II | LITHOTRIPTER | LNS | DORNIER MEDTECH SYSTEMS GMBH | COMPACT DELTA II |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |