FDA Adverse Event
Malfunction
Summary report: N
SONOTAP
MDR report key: 5596957
·
Received April 22, 2016
Report
- Report Number
- 9611612-2016-00051
- Event Type
- Malfunction
- Date Received
- April 22, 2016
- Date of Event
- April 18, 2016
- Report Date
- September 26, 2016
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- PMA / PMN Number
- K113207
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH GERMAN DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. 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. NOT YET RETURNED.
Additional Manufacturer Narrative · 1
BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED.
Description of Event or Problem · 1
INTERNAL REPORT-NUMBER: (B)(4). TENTATIVE SUMMARIZING TRANSLATION OF INITIAL REPORTER'S NARRATIVE: NEEDLES WERE BLOCKED/ PARTIALLY BLOCKED; 3 NEEDLES INVOLVED.
Description of Event or Problem · 1
(B)(4). TENTATIVE SUMMARIZING TRANSLATION OF INITIAL REPORTER'S NARRATIVE: NEEDLES WERE BLOCKED/ PARTIALLY BLOCKED; THREE (3) NEEDLES INVOLVED .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254527 | SONOTAP | PERIPHERAL NERVE BLOCK NEEDLE | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 1185-3E080 | 1148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |