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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068505111
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Dyspareunia (4505)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2016, the date the sling was implanted, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeons are: (b)(6).The surgeon for the mesh revision is (b)(6).(b)(4).
 
Event Description
It was reported to boston scientific corporation that an obtryx ii system device was implanted during cat-3 tension free vaginal - trans obturator tape, cystoscopy.Sling procedure for stress incontinence procedures performed on (b)(6) 2016.There were no patient complications during the implant procedure.The patient was diagnosed with vaginal mesh exposure, dyspareunia, male dyspareunia.On (b)(6) 2020, the patient had rigid cystoscopy, incision and exploration of groin, gynaecological examination under anaesthetic, complete removal of mid-urethral sling procedures.As reported by the patient's attorney, the patient experienced an unspecified injury.
 
Event Description
It was reported to boston scientific corporation that an obtryx ii system device was implanted during cat-3 tension free vaginal - trans obturator tape, cystoscopy.Sling procedure for stress incontinence procedures performed on (b)(6) 2016.There were no patient complications during the implant procedure.The patient was diagnosed with vaginal mesh exposure, dyspareunia, male dyspareunia.On (b)(6) 2020, the patient had rigid cystoscopy, incision and exploration of groin, gynaecological examination under anaesthetic, complete removal of mid-urethral sling procedures.
 
Manufacturer Narrative
Block b3 date of event: date of event was approximated to april 18, 2016, the date the sling was implanted, as no event date was reported.Block e1: (b)(6).The surgeon for the mesh revision is (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2006 captures the reportable event of erosion.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.Block h11: blocks b5, h6 and h10 have been corrected.
 
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Brand Name
OBTRYX II SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
FREUDENBERG MEDICAL MIS INC
2301 centennial boulevard
jeffersonville IN 47130
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15920484
MDR Text Key304847850
Report Number3005099803-2022-07141
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K121754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/14/2018
Device Model NumberM0068505111
Device Catalogue Number850-511-5
Device Lot NumberML00003080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/11/2022
Initial Date FDA Received12/05/2022
Supplement Dates Manufacturer Received12/05/2022
Supplement Dates FDA Received12/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient Age43 YR
Patient SexFemale
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