MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; ELECTRIC BED

Catalog Number MDR107003ELO

Device Problem Protective Measures Problem (3015)

Patient Problem Laceration(s) (1946)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

A (b)(6) year old hospice resident with dementia got out of bed unassisted.He apparently walked around the bed, slipped and fell backwards onto an uncovered hand-crank connection that is located at the foot of the bed.When he fell, he suffered a severe laceration of his buttocks.He was hospitalized for 3-4 days and subsequently returned to the hospice unit.The bed was not being operated at the time of the incident.The facility has since covered the connection with a protective cap.

Event Description

A resident with dementia got out of bed, slipped and fell onto an uncovered hand crank connection at the foot of the bed.

• Type of Device: ELECTRIC BED
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5853188
• MDR Text Key: 51368573
• Report Number: 1417592-2016-00079
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/08/2016

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?: No
• Device Operator: Other
• Device Catalogue Number: MDR107003ELO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Nursing Home
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2015
• 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): Hospitalization; Other
• Patient Age: 91 YR