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Model Number TEM1409GL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Pain (1994); Urinary Retention (2119); Hernia (2240); Discomfort (2330); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: ethicon-proximate linear cutter with titanium staples, product id: tlc75, (lot# r40j74), exp.Date 2023-05.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 therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced hernia recurrence, acute urinary retention, scrotal edema, hematoma, and pain/discomfort.Post-operative patient treatment included orchiectomy.
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Search Alerts/Recalls
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