A voluntary event report mw5089792 was received by deroyal industries, inc.On 10/14/2019, indicating the patient became agitated and broke bilateral medical soft wrist restraints.The event was reported as a serious injury requiring intervention.The part number was not provided within the initial report.The quality assurance manager for complaints has made three attempts to the contact the email address that was provided, to obtain additional information.The email attempts were made on 10/14/2019, 10/16/2019 and 10/22/2019.A voice mail attempt was also made on 10/14/2019, using the phone number that was provided in the initial report.The part number and or sample has not been received at this time to be able to complete a thorough investigation.We were unable to find evidence of shipping any products to the reporting customer.Also, listed on our instructions for use for our limb holder one of the contraindications states - do not use on a patient who is or may become highly aggressive or agitated.The investigation is complete at this time.We will provide a follow up report if additional information becomes available.
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