SILICONE PIP SZ. 1 SPIP-520-1-WW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-12 for SILICONE PIP SZ. 1 SPIP-520-1-WW manufactured by Ascension Orthopedics.

MAUDE Entry Details

Report Number1651501-2019-00036
MDR Report Key8883860
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-08-12
Date of Report2019-07-16
Date of Event2019-07-16
Date Mfgr Received2019-07-16
Date Added to Maude2019-08-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER VIVIAN NELSON
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1ASCENSION ORTHOPEDICS
Manufacturer Street8700 CAMERON ROAD #100
Manufacturer CityAUSTIN TX 78754
Manufacturer CountryUS
Manufacturer Postal Code78754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSILICONE PIP SZ. 1
Generic NameSILICONE PIP
Product CodeKYJ
Date Received2019-08-12
Catalog NumberSPIP-520-1-WW
Lot Number192715T
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer Address8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-12

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