PENCAN N/A 4502052N-01

MAUDE Adverse Event Report

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 2019-11-13 for PENCAN N/A 4502052N-01 manufactured by B. Braun Melsungen Ag.

MAUDE Entry Details

Report Number9610825-2019-00524
MDR Report Key9315222
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-13
Date of Report2019-11-13
Date Mfgr Received2019-10-25
Device Manufacturer Date2017-12-06
Date Added to Maude2019-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SEVERINO
Manufacturer Street861 MARCON BOULEVARD
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
Manufacturer Phone4842408332
Manufacturer G1B. BRAUN MELSUNGEN AG
Manufacturer StreetCARL-BRAUN-STR. 1
Manufacturer CityMELSUNGEN, 34212
Manufacturer CountryGM
Manufacturer Postal Code34212
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENCAN
Generic NameNEEDLE, SPINAL, SHORT TERM
Product CodeMIA
Date Received2019-11-13
Returned To Mfg2019-11-08
Model NumberN/A
Catalog Number4502052N-01
Lot Number17N06H8B22
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MELSUNGEN AG
Manufacturer AddressCARL-BRAUN-STR. 1 MELSUNGEN, 34212 GM 34212


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-13

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