MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-27 for PERIFIX? 4514017C manufactured by B. Braun Melsungen Ag.
Report Number | 9610825-2020-00039 |
MDR Report Key | 9765100 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-02-27 |
Date of Report | 2020-02-27 |
Date of Event | 2020-01-25 |
Date Mfgr Received | 2020-01-30 |
Device Manufacturer Date | 2019-08-08 |
Date Added to Maude | 2020-02-27 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. JONATHAN SEVERINO |
Manufacturer Street | 861 MARCON BLVD. |
Manufacturer City | ALLENTOWN PA 18109 |
Manufacturer Country | US |
Manufacturer Postal | 18109 |
Manufacturer Phone | 4842408332 |
Manufacturer G1 | B. BRAUN MELSUNGEN AG |
Manufacturer Street | CARL-BRAUN-STR. 1 |
Manufacturer City | MELSUNGEN, |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PERIFIX? |
Generic Name | CATHETER, CONDUCTION, ANESTHETIC |
Product Code | BSO |
Date Received | 2020-02-27 |
Returned To Mfg | 2020-02-10 |
Catalog Number | 4514017C |
Lot Number | 19H08A8701 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | B. BRAUN MELSUNGEN AG |
Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-27 |