BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number 850-700 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Erosion (1750); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 04/26/2021 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a solyx sling was implanted into the patient on (b)(6) 2014.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; perineum pain; anal pain; rectal pain; thigh pain; painful intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric injury surgical interventions: on (b)(6) 2021 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: emergency perineal abscess surgery - massive horseshoe internal infection.On (b)(6) 1921 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: fistula repair (following infection above).
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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Correction: b5, h6 patient codes.Block a1: (b)(4).Block d4, h4: 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 h6: evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.
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Event Description
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It was reported to boston scientific corporation that a solyx sling was implanted into the patient on (b)(6) 2014.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; perineum pain; anal pain; rectal pain; thigh pain; painful intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric injury surgical interventions: on (b)(6) 2021 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: emergency perineal abscess surgery - massive horseshoe internal infection.On (b)(6) 2021 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: fistula repair (following infection above).
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Search Alerts/Recalls
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