FDA Adverse Event
Malfunction
Summary report: N
INFILTRALONG
MDR report key: 6059535
·
Received October 27, 2016
Report
- Report Number
- 9611612-2016-00145
- Event Type
- Malfunction
- Date Received
- October 27, 2016
- Report Date
- April 3, 2017
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSO
- UDI-DI
- 04048223016039
- PMA / PMN Number
- K080675
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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.
Description of Event or Problem · 1
(B)(4). DATE OF EVENT IS UNKNOWN/ HAS NOT BEEN REPORTED. SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER'S NARRATIVE: CATHETER SPLIT APART DURING USE.
Description of Event or Problem · 1
(B)(4). DATE OF EVENT IS STILL UNKNOWN AND HAS NOT BEEN REPORTED. SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: CATHETER SPLIT APART DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712084 | INFILTRALONG | PERIPHERAL NERVE BLOCK CATHETER | BSO | PAJUNK GMBH MEDIZINTECHNOLOGIE | 001158-10A | 1145 | 04048223016039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |