30 SILICONE PIP IMPLANT (STERILE PACKED) PIP30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-22 for 30 SILICONE PIP IMPLANT (STERILE PACKED) PIP30 manufactured by Stryker Gmbh.

Event Text Entries

[124605479] Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[124605480] Setting up autofix screw 2. 0. One month after appearance of an inflammatory phenomenon with redness and digital swelling in two patients. Inflammatory reaction and local discomfort for patients. This pi represents the second patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2018-00884
MDR Report Key7992294
Report SourceHEALTH PROFESSIONAL
Date Received2018-10-22
Date of Report2018-11-16
Date of Event2018-08-23
Date Mfgr Received2018-10-25
Date Added to Maude2018-10-22
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. ANNA JUSINSKI
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 Report3

Device Details

Brand Name30 SILICONE PIP IMPLANT (STERILE PACKED)
Generic NamePROSTHESIS, FINGER, CONSTRAINED, POLYMER23
Product CodeKYJ
Date Received2018-10-22
Catalog NumberPIP30
Lot Number04912L
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-10-22

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