MAUDE Adverse Event Report: DRIVE MEDICAL LATERAL ROTATION MATTRESS

Model Number LS9500

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 10/22/2016

Event Type  Injury  

Event Description

Ordered a drive medical lateral rotation mattress.Directions were terrible, no precautions or what to put on top of the mattress.Tried to find out online and was told you didn't need anything, but could put a loose fitting flat sheet.Well the sheet moves, my husband who is bedridden, during the rotation period, his arm slipped into the gully between the mattress and bolster and i didn't know this and when the home health aides came, they found his skin had peeled off and he was bleeding.They took care of it till the nurse came in on sunday and cleaned and dressed it.They both took photographs which i don't have access to but i took a video next day.I reported it to drive medical and heard nothing.They need to put a warning in the booklet that stresses the dangers of the lateral rotation mode and that a sheet, preferably a fitted be used.My husband loves the bed and my complaint is a safety issue.We do not want to return the bed.I'm reporting this to help others who don't know.If i knew this would happen, i would have just ordered a (b)(6) version without the rotation but spent (b)(6) in total for this device.

• Brand Name: LATERAL ROTATION MATTRESS
• Type of Device: MATTRESS
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 6063525
• MDR Text Key: 58652273
• Report Number: MW5065671
• Device Sequence Number: 1
• Product Code: IKY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/27/2016

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: Other
• Device Model Number: LS9500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; CALCIUM; DEXAMETHASONE; LASIX; OTC MEDS: VITAMIN D; PANTOPRAZOLE; POTASSIUM; RX MEDS: FULL ELECTRIC BED
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 113