FDA Adverse Event
Malfunction
Summary report: N
SONOTAP
MDR report key: 6150244
·
Received December 7, 2016
Report
- Report Number
- 9611612-2016-00154
- Event Type
- Malfunction
- Date Received
- December 7, 2016
- Date of Event
- November 15, 2016
- Report Date
- March 14, 2017
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- UDI-DI
- 04048223019764
- PMA / PMN Number
- K113207
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, THE DATA IS POOR AND THE DEVICE HAS NOT BEEN SENT BACK/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.
Additional Manufacturer Narrative · 1
BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
(B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: NEEDLE IS BLOCKED.
Description of Event or Problem · 1
(B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: NEEDLE IS BLOCKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801088 | SONOTAP | PERIPHERAL NERVE BLOCK NEEDLE | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 1185-3E080 | 1151 | 04048223019764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |