Medicines and Healthcare products Regulatory Agency issues Medical Device Alert over Gel-E Donut and Squishon 2 neonatal and paediatric support devices manufactured by Philips Healthcare
The Gel-E Donut is one of two products covered by the Medical Device Alert
A warning has been issued after mould was discovered on gel-filled cushions designed for use among children and babies.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medical Device Alert concerned Gel-E Donut and Squishon 2 neonatal and paediatric support devices manufactured by Philips Healthcare.
The warning covers all batches of Gel-E Donut with part numbers 92025-A, 92025-B, and 92025-C; and Squishon 2 part number 91033-2.
These gel-filled products are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head or body.
However, Philips Healthcare is aware of mould growth on these neonatal and paediatric support devices. The mould has been identified as Cladosporium and Penicillium fungi.
It is feared this could lead to a risk of infection, breathing difficulties and allergic reactions.
The Medical Device Alert follows an earlier revised Field Safety Notice issued by the manufacturer.
The latest guidance urges caregivers to stop using all these devices, even if they can’t see any mould on them. They must then be disposed of according local environmental guidelines.
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