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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068504000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fatigue (1849); Muscle Weakness (1967); Pain (1994); Burning Sensation (2146); Urinary Frequency (2275); Prolapse (2475); Sleep Dysfunction (2517); Constipation (3274); Balance Problems (4401); Fecal Incontinence (4571); Urinary Incontinence (4572)
Event Date 05/05/2021
Event Type  Injury  
Manufacturer Narrative
Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e1705 captures the reportable event of radiating burns.Imdrf impact code f19 captures the reportable event of the device being explanted.
 
Event Description
It was reported to boston scientific corporation that an obtryx system - curved device was implanted during a procedure performed on (b)(6) 2016.It was noted that the pain was felt in the abdomen, genitals, groin, lower back, perineum, and thighs.Additionally, symptoms of burning sensation, sleep problems, fatigue, loss of balance, muscle weakness, pollakiuria, urinary and fecal leakages, constipation, and prolapse were reported.It was indicated that the patient presented difficulties during prolonged walking, prolonged sitting, and during certain movements such as practicing sports, or during intimate relationships.Therefore, the patient noted their daily life had been compromised.It was detailed that an explant date was performed on may 05, 2021.Boston scientific has been unable to obtain additional information regarding the device location and patient outcome to date.
 
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Brand Name
OBTRYX SYSTEM - CURVED
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
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key19101471
MDR Text Key340100196
Report Number2124215-2024-22422
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729718963
UDI-Public08714729718963
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K040787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/12/2024
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 Date05/17/2019
Device Model NumberM0068504000
Device Catalogue Number850-400
Device Lot Number0000031402
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/04/2024
Initial Date FDA Received04/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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