BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507010 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430)
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Event Date 07/03/2023 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a solyx sis system was used during a transvaginal surgery procedure performed on (b)(6), 2022.As reported by the patient's attorney, the patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm.Due to the pain and complications, the physician fully removed the sling implant on (b)(6), 2023.However, the clamps from the system were left on the patient's bladder, causing continuous pain and suffering.
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Manufacturer Narrative
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Block b3: the exact event onset date is unknown.The provided event date of (b)(6), 2023, was chosen as a best estimate based on the date when patient had an explant procedure due to significant pain.Blocks 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.Block e1: this event was reported by the patient's legal representation.The implanting and explanting surgeon is dr.(b)(6).(b)(6).Block h6: patient code e2330 captures the reportable event of "significant pain." patient code e2308 captures the reportable event of "disfigurement." patient code e0206 captures the reportable event of "unnecessary expense" and "embarrassment." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Impact code f1903 captures the reportable event of device explant procedure performed on (b)(6), 2023.
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Manufacturer Narrative
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D4: model number, d4: lot number, d4: expiration date have been updated based on the additional information received on march 29, 2024.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2023, was chosen as a best estimate based on the date when patient had an explant procedure due to significant pain.Block e1: this event was reported by the patient's legal representation.The implanting and explanting surgeon is (b)(6).Block h6: patient code e2330 captures the reportable event of "significant pain." patient code e2308 captures the reportable event of "disfigurement." patient code e0206 captures the reportable event of "unnecessary expense" and "embarrassment." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Impact code f1903 captures the reportable event of device explant procedure performed on (b)(6) 2023.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system was used during a transvaginal surgery procedure performed on (b)(6) 2022.As reported by the patient's attorney, the patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm.Due to the pain and complications, the physician fully removed the sling implant on (b)(6) 2023.However, the clamps from the system were left on the patient's bladder, causing continuous pain and suffering.
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Search Alerts/Recalls
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