Uresta Bladder Support (2018-11-04)
- Starting date:
- November 4, 2018
- Posting date:
- November 28, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68444
Affected products
Uresta Bladder Support
Reason
Southmedic received notification of a customer complaint in which a patient with a previous mesh tape operation, which is still located internally, used the Uresta Bladder Support on the suggestion of a physician. Based on clinical feedback, the results of the investigation indicate that the complaint is most likely attributed to use in a way for which the device was not designed The reason for the recall is to provide an additional precaution statement to the IFU for further clarity to customers.
Affected products
Uresta Bladder Support
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- UR202
- UR203
- UR204
- UR205
- UR206
- UR208
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
CANADA