MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WHEELCHAIR,K1 BASIC,18",DLA,ELR FOOT

Catalog Number MDS806300EE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Inadequate Pain Relief (2388)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Phone call placed to end user, who provided additional information in regards to this incident.End user reports, "i was going up a cement ramp outside when the wheelchair lost its traction and i slipped backward resulting in the chair flipping straight backward and i struck the back of my head and ribs forcefully on the cement." end user reports, he was assisted up and back into the wheelchair.End user states he did not seek medical attention that day but waiting until the following morning (b)(6) 2021 when he was in extreme pain.End user reports he went to the local emergency room where he reports several x-rays and a cat scan were completed.End user reports he has several fractured ribs and is in extreme pain.End user states, he was released that same day (b)(6) 2021 from the emergency room with an order to follow-up with his primary care physician, which he reports, he did on (b)(6) 2021.End user reports, "they are not giving me enough pain medication.I have degenerative disk disease, and had my leg amputated (b)(6) of last year (2020), i need pain medication!" sample is available for return; however, at the time of this report end user has not returned the sample for evaluation.End-user reports he will be requesting restitution in addition to a replacement wheelchair.Due to the reported incident, medical intervention 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 end user fell and fractured multiple ribs.Medical intervention was required.

Manufacturer Narrative

Supplemental documentation changed/additional information added.D9 device available for evaluation -no.G6 type of report - follow-up-01 h2 if follow-up what type? additional information.H3 device evaluated by manufacturer - no, not returned to manufacturer.H6 type of investigation- 4110, 4114 h5 investigation conclusion - zcd00006/unconfirmed defect h10 investigation report reads as follows: 04/23/2021 10:41:23 cst (bschauer) "investigation results: not confirmed root cause: not confirmed / no sample received.Sample/photo provided: none.Investigation description: "complaint could not be confirmed as there were no samples or pictures received.Without a sample received, it is difficult to determine a true root cause for the reported issue.The division performs quarterly trending on all complaints received, and will initiate further investigation and/or supplier corrective action requests based on trending results.Should the sample/detailed picture become available, we will reopen the complaint and investigate accordingly.Will initiate further investigation and/or supplier corrective action requests based on trending results.Should the sample/detailed picture become available, we will reopen the complaint and investigate accordingly.".

Event Description

It was reported end user fell and fractured multiple ribs.Medical intervention was required.

• Type of Device: WHEELCHAIR,K1 BASIC,18",DLA,ELR FOOT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11613282
• MDR Text Key: 254931663
• Report Number: 1417592-2021-00051
• 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
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS806300EE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 82