Model Number 72912 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 11/01/2013 |
Event Type
Injury
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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) 2013.The patient experienced complications 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; painful intercourse; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury.Nonsurgical treatments: on (b)(6) 2013 the patient commenced pain medication: paracetamol for the treatment of: analgesia.Treatment duration: 8 years.On (b)(6) 2013 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: strengthen pelvic floor muscles.Treatment duration: 8 years.
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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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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) 2013.The patient experienced complications 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; painful intercourse; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury.Nonsurgical treatments: on (b)(6) 2013 the patient commenced pain medication: paracetamol for the treatment of: analgesia.Treatment duration: 8 years.On (b)(6) 2013 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: strengthen pelvic floor muscles.Treatment duration: 8 years.
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Search Alerts/Recalls
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