MAUDE Adverse Event Report: ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. DEROYAL; LIMB HOLDER

Model Number NOT PROVIDED

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Patient became agitated and broke bilateral medical soft wrist restraints.

• Brand Name: DEROYAL
• Type of Device: LIMB HOLDER
• Manufacturer (Section D): ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a; villa canales; villa canales, 01065 ; GT 01065
• Manufacturer (Section G): ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a; villa canales; villa canales, 01065 ; GT 01065
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 9246283
• MDR Text Key: 178640648
• Report Number: 3010452421-2019-00002
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention