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Model Number PP1510X3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Incontinence (1928); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Dysuria (2684); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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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 vaginal vault prolapse.
It was reported that after the implant, the patient experienced an unspecified adverse outcome.
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Search Alerts/Recalls
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