BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number 850-411 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
|
Event Date 10/07/2017 |
Event Type
Injury
|
Event Description
|
Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the obtryx ii.It was reported to boston scientific corporation that an uphold lite prolapse mesh and an obtryx ii incontinence sling were implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: mesh removal.On (b)(6) 2018 the patient underwent further surgery for the following purpose: laparoscopic poca vaginal repair, burch colposuspension enterocele repair, posterior vaginal repair and removal of residual mesh.
|
|
Manufacturer Narrative
|
Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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.
|
|
Manufacturer Narrative
|
Block a1: (b)(4).Block d4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.Block h10: the complainant indicated that the device is not available for return; 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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06642.
|
|
Event Description
|
Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the obtryx ii.It was reported to boston scientific corporation that an uphold lite prolapse mesh and an obtryx ii incontinence sling were implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage surgical interventions: on (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: mesh removal.On (b)(6) 2018 the patient underwent further surgery for the following purpose: laparoscopic poca vaginal repair, burch colposuspension enterocele repair, posterior vaginal repair and removal of residual mesh.
|
|
Search Alerts/Recalls
|
|
|