AEMPS issues warnings for medical device defects

The Spanish Agency for Medicines and Health Products (AEMPS) has issued warnings regarding potential defects in two different medical devices.

First, Dynavox Group AB (Sweden) reported a mechanical resistance issue in the TD Navio Midi and TD Navio Maxi augmentative and alternative communication devices. Distributed in Spain by Qinera, these devices help individuals with speech and language disorders. A failure in the internal battery fixation could lead to short circuits, localized heating, or gas release if the product suffers heavy drops or mechanical stress. Affected serial numbers for the Midi and Maxi models have been specified by the agency.

Second, Hollister Incorporated (USA) reported a manufacturing defect in Onli hydrophilic intermittent urethral catheters. A protrusion located approximately 2 cm from the drainage path may cause patient discomfort, genitourinary trauma, or hemorrhage. The warning affects various lot sizes ranging from 8 cm to 40 cm. Patients and caregivers are advised to visually inspect catheters for protrusions before use.