MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG, INC. ROTOPRONE BED; BED, PATIENT ROTATION, POWERED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 07/30/2017

Event Type  Injury  

Event Description

I took lyrica and a cough syrup containing hydrocodone prescribed by same md and filled at same pharmacy.My husband woke to find me unresponsive.He called 911.I was taken to (b)(6) where i remained in a coma, in icu, 6 broken ribs from cpr.No one told me about this deadly combination.I still have breathing difficulties.I have scars on my face from being placed incorrectly in a rotoprone bed, something else you should look into.When i came across the information about lyrica on this website, i began the process of weaning off.It's a miserable drug that should be pulled off the shelves.The withdrawals are incapacitating.Handing patients, a long winded "information" sheet, filled with terrifying potential side effects does not relieve the doctor, pharmacist and manufacturers of responsibility for what happened to me.My medical records are at (b)(6) and i don't know what lab tests to include here.I am not a doctor.Nerve pain erythromelalgia.

• Brand Name: ROTOPRONE BED
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG, INC.
• MDR Report Key: 11010567
• MDR Text Key: 221558705
• Report Number: MW5098349
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): Y
• 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: 12/10/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Patient Sequence Number: 1
• Treatment: LYRICA; MULTI VITAMIN; NEXIUM
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 58 YR