MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-K3 BASIC,18,ADJ,DLA,S/A FT,ANTI-TIP

Catalog Number MDS806600EPL

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "patient fell when getting in the chair.Chair unlocked and it moved and the patient fell." email received by (b)(6), identified as patient/end user's caregiver.Reporter states, the k3 basic lightweight wheelchair was, "purchased around (b)(6) 2021, through dr.(b)(6) office or possibly from (b)(6) medical supplies (reporter is unsure)." reporter states, item was purchased through insurance and they have no receipt of purchase.Reportedly, "the brakes began to malfunction around the beginning of (b)(6) 2021." reporter states, "the incident occurred on (b)(6) 2021 around 3pm.There was no serious injuries involved, only bruised shoulder & arm." reporter states, "end user went to emergency room on (b)(6) 2021 for a feeding tube replacement and complained about bruising shoulder and arm in a fall.End user was prescribed the following medications; lidocaine 5% (lidoderm) patch and methocarbamol (robaxin) 500 mg tablets." no follow-up appointments are scheduled and end user was not admitted to the hospital.End user is doing well at this time.The sample has not been returned at the time of this report filing.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported, "patient fell when getting in the chair.Chair unlocked and it moved and the patient fell.".

• Type of Device: DBD-K3 BASIC,18,ADJ,DLA,S/A FT,ANTI-TIP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12508517
• MDR Text Key: 277722928
• Report Number: 1417592-2021-00177
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS806600EPL
• Device Lot Number: U201104733
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 73