MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; HALF RAIL FOR MEDLINE HOME CARE BEDS

Catalog Number MDS86420

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

It was reported the end user fell while transferring from a chair back into the bed due to the half rail not being secured properly to the bed.The reporter states the end user fell onto the floor striking and injuring his left shoulder and arm.The end user was taken to the hospital where he was admitted and treated for a left shoulder and arm fracture.The reporter states, "when the hospital bed and side rails, were delivered by the durable medical equipment company something underneath the bed a long poll or rod was not connected, it's just hanging and sitting on the floor".The reporter also stated, "the half rail has been loose ever since the bed was delivered and that someone was supposed to come back with a part or piece to fix the bed/rails".The sample was not returned to the manufacturer for evaluation.A definitive root cause for the reported issue could not be determined as a result.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported the end user fell while transferring from a chair back into the bed due to the half rail not being secured properly to the bed.

• Type of Device: HALF RAIL FOR MEDLINE HOME CARE BEDS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10171642
• MDR Text Key: 195904485
• Report Number: 1417592-2020-00061
• Device Sequence Number: 1
• Product Code: FNJ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 95