MAUDE Adverse Event Report: MJM INTERNATIONAL CORP. LARGE RECLING BATH/SHOWER CHAIR

Model Number 191-LC-B-HB

Device Problems Device Unsafe to Use in Environment (2918); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

We purchased a 191-lc-b-hb bath chair (durable medical equipment) for our daughter from tiger medical.The mfr is mjm international corp.This bath chair only comes with 2 locking wheels for the back.This is a safety hazard.All 4 wheels should lock.I called mjm international corp about this.They said the chair only comes with 2 locking wheels, but if i want to upgrade to 4 locking wheels, i should go back to (b)(4) to order them.This is wrong, it is a safety hazard that mjm only provided 2 locking wheels.The chair moves around the tips when i am putting my daughter in the bath chair.Mjm refuses to listen to me about how unsafe this is.

• Brand Name: LARGE RECLING BATH/SHOWER CHAIR
• Type of Device: LARGE RECLING BATH/SHOWER CHAIR
• Manufacturer (Section D): MJM INTERNATIONAL CORP.
• MDR Report Key: 7273156
• MDR Text Key: 100425093
• Report Number: MW5075257
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 191-LC-B-HB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 36