MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; WALKER

Catalog Number MDS86410XW

Device Problem Insufficient Information (3190)

Patient Problem Dehydration (1807)

Event Date 05/28/2016

Event Type  Injury  

Manufacturer Narrative

The end user reported that while she was using the walker to transfer herself from a chair to an electric wheelchair, the walker collapsed.She fell to the floor.She was transported to the hospital where she was admitted for dehydration and an electrolyte imbalance.The fall was unwitnessed.She was admitted into the hospital due to other health issues unrelated to the fall.The sample was not returned for evaluation.A root cause has not been determined.Due to the reported admission and in an abundance of caution, this medwatch is being filed.

Event Description

It was reported that the end user fell while using the walker and was admitted into the hospital.

• Type of Device: WALKER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5754500
• MDR Text Key: 48300743
• Report Number: 1417592-2016-00067
• 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: Patient
• Type of Report: Initial
• Report Date: 06/27/2016

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: Lay User/Patient
• Device Catalogue Number: MDS86410XW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 72 YR
• Patient Weight: 118