XENFORM M0068302430 830-243

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 2020-03-16 for XENFORM M0068302430 830-243 manufactured by Boston Scientific Corporation.

Event Text Entries

[186350175] (b)(4). The device has not been received for analysis; 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


[186350176] It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence (sui), and was implanted with a xenform device and a non-bsc device on (b)(6) 2017. As reported by the patient's attorney, on (b)(6) 2017, the patient underwent a revision surgery related to the xenform device and a non-bsc device due to the associated post-operative diagnosis of vaginal foreign body dermis in the anterior vagina, in the posterior vagina, and suburethral. Boston scientific has been unable to obtain additional information regarding the event to date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-01026
MDR Report Key9834259
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2017-12-05
Date Mfgr Received2020-02-19
Device Manufacturer Date2017-02-01
Date Added to Maude2020-03-16
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
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
Generic NameMESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
Product CodeFTM
Date Received2020-03-16
Model NumberM0068302430
Catalog Number830-243
Lot Number0001701024
Device Expiration Date2019-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-16

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