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

Catalog Number	WRX276733
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	07/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the customer was using a bath bench in the shower and while the end-user was sitting on the bench, washing his upper torso, the leg broke off of the bench after which the end-user fell onto the tile shower floor.After the incident the end-user noticed that his left leg was bleeding, his right leg was scuffed and bruised and his right foot had a few cuts.The end-user reported that his right wrist and shoulder were also swollen with a cut on the back of his head.There was no medical treatment obtained at the time of the incident, the end-user reported that he took one of his pain pills and went to bed.The end-user reported that he woke up in pain the next morning (exact time period unreported) and decided to go to his doctor.The end-user reported that he had unspecified x-rays from an orthopedic doctor and results were noted to be negative for fractures.The end-user reported that his bruises are resolving and the right foot, which developed an infection after the incident, is being treated with unspecified intravenous (iv) antibiotics.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product or incident details to the manufacturer.No sample has been received for evaluation.Due to the reported incident, required medical intervention for the infection and in an abundance of caution, this is an mdr reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that while the end-user was sitting on the bath bench one of the legs on the bath bench broke and the end-user fell.

• Common Device Name: MICROBAN BENCH,BATH, NO BACK, KNOCKDOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8945959
• Report Number: 1417592-2019-00152
• Device Sequence Number: 16201573
• Product Code: ILS
• UDI-Device Identifier: 00311917158853
• UDI-Public: 00311917158853
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: WRX276733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 68