MAUDE Adverse Event Report: UNKNOWN AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS; 880.5100

Model Number UNKNOWN

Device Problem Mechanics Altered (2984)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Shock (2072); Injury (2348)

Event Type  Injury  

Event Description

End user stated that she was getting out of the unknown model bed, had 1 leg on the floor and her knee on the bed.As she was moving her leg to the floor she felt a scrape and went into shock.End user stated she screamed non stop for over 30 minutes.States she lost a lot of blood and it took over an hour at the emergency room to reattach her skin.End user states that the post where the bed rails go into the bed caught her leg and pulled the skin up, tearing the meat backward.End user stated she was in a lot of pain, a gouge of skin was cut loose from the back of her leg.He i jury allegedly required 3 stitches, one in each corner to hold the chunk of skin in place and 18 staples to seal the skins 3 areas.End user is required to wear a boot to keep her from bending her toes downward and ripping the skin back open.Invacare spoke to the end user who stated that she saw a spider on the wall and was scared, tried to get out of bed in a hurry and alleges that the bed rail socket was sharp and ripped her skin off.

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4191705
• MDR Text Key: 20272225
• Report Number: 1525712-2014-07151
• Device Sequence Number: 1
• Product Code: FNL
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention