MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BATH BENCH, NO BACK

Catalog Number MDS89740RH

Device Problem Collapse (1099)

Patient Problem Contusion (1787)

Event Date 12/26/2014

Event Type  Injury  

Event Description

The end user was sitting on the bench and turned to get off.The bench apparently collapsed and he suffered contusions on his left hip.

Manufacturer Narrative

The end user was sitting on the bath bench and turned to get out of the shower.The bench collapsed and he fell suffering a left hip contusion.He sought treatment from his chiropractor.The sample was returned and evaluated.The frame was bent in the middle section.There were no issues found with the bolts and threaded inserts.The leg extensions and push pins were working as intended.There were no mfg defects found and a root cause has not been identified.The end user was evaluated and no fracture was diagnosed.Due to the intervention of his chiropractor and in an abundance of caution, this medwatch is being filed.

• Brand Name: BATH BENCH, NO BACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4528425
• MDR Text Key: 5508723
• Report Number: 1417592-2015-00011
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS89740RH
• Device Lot Number: E140105528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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: 51 YR
• Patient Weight: 107