Device product
Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.
Z-1952-2019
Product summary
- Event
- Event 83023
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1024 (180 distributed from distributor)
- Official record key
device-enforcement:Z-1952-2019
Official wording
Reason: The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).
Code information: Lot 75770223
Distribution pattern: US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.
Derived failure modes
-
Unknown
The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).