MAUDE Adverse Event Report: "TUFF CUFFS" MEDICAL FOUR-POINT RESTRAINT SYSTEM; RESTRAINT, PROTECTIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/17/2016

Event Type  Injury  

Event Description

Exacerbation of preexisting; i was severely injured, including five days of hospitalization and another week with a home health aide, due to the improper use of a restraint device and/or bedrails at (b)(6).I have since filed a lawsuit since their improper use resulted in permanent disability.In the discovery process, i have also learned that there is contradictory information regarding which types of restraints were used, whether they were the leather hard restraints, or the "soft," black, plastic, thin velcro straps i remember seeing.I have severe anesthesia emergence delirium, which i informed staff of prior to an out-patient endoscopy procedure, in addition to my multiple other serious medical conditions, including dysautonomia, fibromyalgia and chronic low back problems.Staff violated my informed consent with regard to the use of these injurious devices, committed medical battery and caused me permanent injury and disability.I have a lengthy narrative regarding this incident which i can provide, in addition to the policies and procedures manuals from the hospital with regard to the use of restraints, which, from the documentation provided to me, medical personnel and security guards violated, with regard to documentation and reporting to state investigators in the wake of a serious injury resulting from a restraint procedure.Fda safety report id # (b)(4).

• Brand Name: "TUFF CUFFS" MEDICAL FOUR-POINT RESTRAINT SYSTEM
• Type of Device: RESTRAINT, PROTECTIVE
• MDR Report Key: 13473414
• MDR Text Key: 285413409
• Report Number: MW5107263
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/02/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2022
• Patient Sequence Number: 1
• Treatment: FLEXERIL ; IBUPROFEN ; MELOXICAM ; NIZORAL SHAMPOO
• Patient Outcome(s): Disability; Other; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female