Model Number 72912 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Prolapse (2475); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 12/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2008.A second upsylon y-mesh implant was implanted into the patient on (b)(6) 2019.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; off vag dis; diff bowel; incont not pres; rec incont; aggrav incont; psych; oth pain: headaches, pain all over surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: prolapse again even after first mesh implant and sling.Nonsurgical treatments: on (b)(6) 1997 the patient commenced pain medication: panadol and asprin for the treatment of: pain.Treatment duration: ongoing whole life to try and cope with pain.On (b)(6) 2021 the patient commenced incontinence medication: oxybutynin for the treatment of: bladder spasms treatment.Treatment duration: for the rest of my life.On (b)(6) 2019 the patient commenced other medication (please specify): ovestin suppository for the treatment of: avoiding infection since surgery.Treatment duration: 3 times a week from (b)(6) 2019 until (b)(6) 2021.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pain and discomfort exercises.Treatment duration: for the rest of my life.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): ovestin cream for the treatment of: avoiding infection and keeping moisture avoiding dryness and discomfort.Treatment duration: for the rest of my life 3 times a week cream instead of suppository.The patient was treated with other (please specify) for the treatment of: prolapse still falling.Treatment duration: for rest of my life.
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Manufacturer Narrative
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Block a1: meshc-20211022-a61b7991.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 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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Note: this report pertains to the first of two upsylon y-mesh devices implanted into the same patient.It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2008.A second upsylon y-mesh implant was implanted into the patient on (b)(6) 2019.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; psychiatric injury; other pain: headaches, pain all over.Surgical interventions: on (b)(6) 2019, the patient underwent further surgery regarding the first upsylon y-mesh implant under general anesthesia for the following purpose: prolapse again even after first mesh implant and sling.Nonsurgical treatments: on (b)(6) 1997, the patient commenced pain medication: panadol and asprin for: pain.Treatment duration: ongoing whole life to try and cope with pain.On (b)(6) 2021, the patient commenced incontinence medication: oxybutynin for: bladder spasms treatment.Treatment duration: for the rest of patient's life.On (b)(6) 2019, the patient commenced other medication (please specify): ovestin suppository for purpose: avoiding infection since surgery.Treatment duration: 3 times a week from december 2019 until september 2021.On (b)(6) 2020, the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for purpose: pain and discomfort exercises.Treatment duration: for the rest of patient's life.On (b)(6) 2021, the patient commenced topical treatment (including oestrogen cream): ovestin cream for the treatment of: avoiding infection and keeping moisture avoiding dryness and discomfort.Treatment duration: for the rest of patient's life 3 times a week cream instead of suppository.The patient was treated with pessary for purpose: prolapse still falling.Treatment duration: for rest of patient's life.
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Search Alerts/Recalls
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