XENFORM SOFT TISSUE REPAIR MATRIX M0068302470

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-17 for XENFORM SOFT TISSUE REPAIR MATRIX M0068302470 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[124066365] Secondary/alternative patient id: (b)(6). Study name: u9920 xenform a/a postmarket. The complainant indicated that the device is implanted and the device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[124066366] It was reported to boston scientific corporation that xenform soft tissue repair matrix was implanted during a pelvic floor repair procedure with xenform including apical vault suspension, vaginal approach hysteropexy, and cystocele repair procedure performed on (b)(6) 2015. According to the complainant, during and after the procedure, the patient experienced bleeding which required blood transfusion. The event resolved on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-02617
MDR Report Key7975840
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-10-17
Date of Report2018-09-19
Date of Event2015-05-04
Date Mfgr Received2018-10-25
Device Manufacturer Date2015-03-02
Date Added to Maude2018-10-17
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 Received2018-10-17
Model NumberM0068302470
Lot Number0001501011
Device Expiration Date2017-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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. Required No Informationntervention 2018-10-17

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