XENFORM SOFT TISSUE REPAIR MATRIX UNK166

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-11-07 for XENFORM SOFT TISSUE REPAIR MATRIX UNK166 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[91220105] As reported by the patient? S attorney, a boston scientific device was implanted. According to the complainant, the patient experienced an unknown injury. All other information is unknown. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2017-03255
MDR Report Key7005946
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2017-11-07
Date of Report2017-10-16
Date Mfgr Received2017-10-16
Date Added to Maude2017-11-07
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 ContactEMP. NANCY CUTINO
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1TEI BIOSCIENCES INCORPORATED
Manufacturer Street7 ELKINS STREET
Manufacturer CityBOSTON MA 02127
Manufacturer CountryUS
Manufacturer Postal Code02127
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXENFORM SOFT TISSUE REPAIR MATRIX
Generic NameMESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
Product CodePAJ
Date Received2017-11-07
Model NumberUNK166
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-07

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