OBTRYX SYSTEM - HALO M0068505000 850-500

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 2020-03-19 for OBTRYX SYSTEM - HALO M0068505000 850-500 manufactured by Boston Scientific Corporation.

Event Text Entries

[184098649] (b)(4). 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


[184098650] It was reported to boston scientific corporation that an obtryx system was implanted into the patient for the treatment of cystourethrocele, stress urinary incontinence (sui) and rectocele during a procedure performed on (b)(6) 2010. As reported by the patient's attorney, the patient was implanted with an additional sling (solyx) on (b)(6) 2012 due to a recurring stress urinary incontinence (sui). 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 Number3005099803-2020-00998
MDR Report Key9852908
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2012-02-03
Date Mfgr Received2020-02-19
Device Manufacturer Date2010-04-08
Date Added to Maude2020-03-19
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 G1FREUDENBERG MEDICAL MIS INC
Manufacturer Street2301 CENTENNIAL BOULEVARD
Manufacturer CityJEFFERSONVILLE IN 47130
Manufacturer CountryUS
Manufacturer Postal Code47130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOBTRYX SYSTEM - HALO
Generic NameMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Product CodeOTN
Date Received2020-03-19
Model NumberM0068505000
Catalog Number850-500
Lot Number1ML0030204
Device Expiration Date2013-03-31
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 2020-03-19

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