MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348)

Event Date 01/02/2015

Event Type  Injury  

Event Description

It has been claimed that the rotoprone device ran over the caregiver's foot.Additionally provided info revealed that as there was no further need of using the rotoprone with the pt, the device was moved from the room.Due to the size of the door frame, it was dismantled.During moving the bed through the door, it ran over the caregiver foot.The caregiver went to the emergency department as his toenail was bloody.Performed x-ray was negative for broken bones, the caregiver returned to work that same day and have been advised to have walking boot for 11 days.Mfr ref #3009988881-2015-00007.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 4433033
• MDR Text Key: 16881263
• Report Number: 1419652-2015-00029
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1