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

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  Reason
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  Affected products

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