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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068505000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 08/03/2016
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2016, implant procedure date, as no event date was reported.Initial reporter name and address: this event was reported to boston scientific corporation legal by the patient's legal representation.The implanting surgeon is (b)(6).(b)(4).
 
Event Description
It was reported to boston scientific corporation that an obtryx system - halo was implanted during a vaginal sling implant and cystourethroscopy procedures performed on (b)(6) 2016 to treat a patient with cystocele and stress urinary incontinence.The patient was taken to the recovery room in good condition.As reported by the patient's attorney, the patient experienced an unspecified injury.
 
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Brand Name
OBTRYX SYSTEM - HALO
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 Key16051486
MDR Text Key306170731
Report Number3005099803-2022-07744
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/27/2022
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 Date05/20/2019
Device Model NumberM0068505000
Device Catalogue Number850-500
Device Lot Number0000031765
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2022
Initial Date FDA Received12/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
Patient SexFemale
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