MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MICROBAN BENCH,BATH,W/ BACK,KNCKDWN

Catalog Number WRX276735

Device Problem Material Twisted/Bent (2981)

Patient Problems Pain (1994); Swelling (2091); Tooth Fracture (2428)

Event Date 09/21/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that after getting out of the shower, the end-user sat down on the bath bench.Per report, the end-user leaned forward to apply his left ankle foot orthosis (end-user has history of drop foot) and the left back leg of the bath bench bent inwards and folded.Reportedly, the end user's leg caught under the chair resulting in his orthosis being damaged.It was added that when end-user fell from sitting on the bath bench, end user hit his head and face onto the floor.One tooth was reportedly "knocked out" and another tooth was "chipped." it was denied that end user went to the emergency room or to a dentist related to the reported event.After the incident, the end- user noted that his ankle foot orthosis "feels tight" and that refitting of the orthosis was required related to the incident with the bath bench.It was also reported that a physician prescribed end-user with diclofenac (anti-inflammatory drug) for his leg swelling.It was denied that any imaging or tests were done.The end-user also reported that his chronic back pain has exacerbated since the incident and that currently, he is using a tens (transcutaneous electrical nerve stimulation) machine to relieve the pain.The bath bench involved in this incident was used for approximately a month.Due to the reported event and the required medical interventions, medwatch is being filed.The sample is not available to be returned for evaluation.Photos of the bath bench were submitted and the issue was confirmed.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that end-user fell from sitting on the bath bench.The end-user reportedly leaned forward and the left back leg of the bath bench bent inwards and folded.

• Type of Device: MICROBAN BENCH,BATH,W/ BACK,KNCKDWN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9215295
• MDR Text Key: 170106957
• Report Number: 1417592-2019-00181
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 10311917158874
• UDI-Public: 10311917158874
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: WRX276735
• Device Lot Number: 64518120025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 109