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UNKNOWN GEL IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05923)

UNKNOWN GEL IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05923) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN GEL IMPLANTS; Generic name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI; Manufacturer: MENTOR TEXAS.

DeviceUNKNOWN GEL IMPLANTS
Generic namePROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI
ManufacturerMENTOR TEXAS
Report number1645337-2020-05923
Event typeInjury
Product problemY
Date received2020-04-28
Report sourceHEALTH PROFESSIONAL
NarrativeCORRECTION: SECTION B5 - THE PATIENT EXPERIENCED UNILATERAL RUPTURE ON THE LEFT SIDE POSTOPERATIVELY. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
SourceopenFDA MAUDE (device adverse events)

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