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Model Number SPMM-149 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Bacterial Infection (1735); Erosion (1750); Fistula (1862); Hematoma (1884); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Discomfort (2330); Injury (2348); 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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Concomitant product: unknown protack (lot # unknown), aris sling (transobturator tape), (lot number: aj060025).
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 laparoscopic therapeutic treatment of a vaginal prolapse and urinary incontinence.
It was reported that after the implant, the patient experienced vaginal discharge and exposure of mesh.
Post-operative patient treatment included excision of small area of exposed mesh.
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Search Alerts/Recalls
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