MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BENCH, BATH, W/BACK AND ARMS,RETAIL

Catalog Number MDS89745RA

Device Problem Break (1069)

Patient Problem Damage to Ligament(s) (1952)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the customer sat on the bench outside of the bathtub before getting in the shower and when he sat back on the chair the backrest of the batch bench snapped backwards resulting in the customer to fall backwards injuring his right arm.It was reported that when the customer fell backwards and his right arm was thrown over the side of the tub resulting in a right distal bicep injury and a tear of the radial collateral ligament.The customer reportedly underwent surgery on (b)(6)2019 to repair the muscle and ligament damage and is currently going to physical therapy twice weekly.The sample was not returned to the manufacturer for evaluation.The customer reported issue was not confirmed and the root cause of the customer reported issue was not determined.No additional information is available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the customer sat on the bath bench and the back rest of the batch bench snapped backwards resulting in the customer to fall backwards injuring his right arm.

• Type of Device: BENCH, BATH, W/BACK AND ARMS,RETAIL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 9475821
• MDR Text Key: 173171233
• Report Number: 1417592-2019-00223
• Device Sequence Number: 1
• Product Code: ILS
• 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: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS89745RA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention