50 SILICONE PIP IMPLANT (STERILE PACKED) PIP50

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for 50 SILICONE PIP IMPLANT (STERILE PACKED) PIP50 manufactured by Stryker Gmbh.

Event Text Entries

[143385085] Upon completion of investigation, additional information will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[143385086] A silicone pip replacement needed to be replaced because of what looks to be material fatigue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2019-00375
MDR Report Key8557907
Date Received2019-04-26
Date of Report2019-07-16
Date of Event2019-04-04
Date Mfgr Received2019-06-18
Date Added to Maude2019-04-26
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 ContactMR. KEVIN SMITH
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name50 SILICONE PIP IMPLANT (STERILE PACKED)
Generic NamePROSTHESIS, FINGER, CONSTRAINED, POLYMER
Product CodeKYJ
Date Received2019-04-26
Returned To Mfg2019-06-06
Catalog NumberPIP50
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-26

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