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

Model Number REF MDS86850EB

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Fall (1848)

Event Date 08/12/2019

Event Type  Injury  

Event Description

Plastic housing inside wheel frame shattered causing wheel to fall off and user to fall.Fda safety report id# (b)(4).

• Brand Name: GUARDIAN
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8939601
• MDR Text Key: 155966283
• Report Number: MW5089374
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REF MDS86850EB
• Device Lot Number: N110117254
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Weight: 75