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Model Number SYM12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: bard capsure permanent fixation system, product id 0113230, lot # hudp0482, exp.Date 2021-01-28, quantity 2.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of a incisional hernia.It was reported that after implant, the patient experienced chronic pain, adhesions, and hernia recurrence.Post-operative patient treatment included revision surgery, and mesh removal surgery.
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Search Alerts/Recalls
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