MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WALKER,ADULT,EX WIDE,5IN WHEELS

Catalog Number MDS86410XWW

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, the push-button lock adjustment is changing on its own.After this was initially reported to medline on 7/26/2021 end user continued to use the walker, experienced the same issue, and fell on (b)(6) 2021.Phone call received by (b)(6), end user, who provided additional information in regards to this incident.(b)(6) confirms that he knowingly continued to use the walker after (b)(6) 2021, knowing the walker was not safe to use.(b)(6) reports the buttons that lock the height adjustment in place had stopped working.(b)(6) reports, that on (b)(6) 2021 at approximately 4 pm he continued to use the walker and experienced the same issue and fell coming into or through the doorway of his apartment complex.End user reports, he hit his head and neck on the doorframe as he fell and was unable to get back to his feet after the fall (due to his size and weight).Ems was contacted.End user reports, he was assisted into his apartment.And declined going to the hospital for evaluation, stating he was "fine, and that he had a regular, scheduled visit with his primary care physician (pcp) the following day (b)(6) 2021." end user reports, while at his medical visit with his pcp he reported the incident with the walker and hitting his head and neck.X-rays were taken of both.End user reports, he is unaware of the results at this time.End user reports the walker was purchased 3/10/2021, and provided lot number (8852010003).End user at this time does not report and other signs or symptoms of pain or discomfort related to this incident.This clinician advised end user against using the walker as end user reports the device is malfunctioning and it poses a risk of injury to himself.Jose states, an understanding.This clinician sent an email seeking additional information from the end-user as it relates to specific information, and medical information.End user reports sample is available for return and evaluation.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, the push-button lock adjustment is changing on its own.After this was initially reported to medline on 7/26/2021 end user continued to use the walker, experienced the same issue, and fell on (b)(6) 2021.

• Type of Device: WALKER,ADULT,EX WIDE,5IN WHEELS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 12331662
• MDR Text Key: 268493678
• Report Number: 1417592-2021-00157
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 08/17/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86410XWW
• Device Lot Number: 8852010003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/17/2021
• 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: 95