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 2017-09-18 for XENFORM SOFT TISSUE REPAIR MATRIX M0068302470 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[86417902] Patient identifier: (b)(6). Report source: study name: (b)(6). The complainant indicated that the device remains implanted and will not 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


[86417903] It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014. According to the complainant, on (b)(6) 2016, the patient experienced fecal incontinence. No treatment has been given and the event has not yet resolved.
Patient Sequence No: 1, Text Type: D, B5


[111532228]
Patient Sequence No: 1, Text Type: N, H10


[111532230] It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014. According to the complainant, on (b)(6) 2016, the patient experienced fecal incontinence. No treatment has been given and the event has not yet resolved. Additional information received on september 27, 2017 the event of fecal incontinence was resolved on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2017-02752
MDR Report Key6871541
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-09-18
Date of Report2017-09-27
Date of Event2016-03-14
Date Mfgr Received2018-09-11
Device Manufacturer Date2014-01-29
Date Added to Maude2017-09-18
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 Received2017-09-18
Model NumberM0068302470
Lot Number0001312018
Device Expiration Date2016-11-30
OperatorPHYSICIAN
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 2017-09-18

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