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

Catalog Number MDS89745R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that while using the shower chair, on (b)(6) 2017, the end user fell and suffered a subdural hematoma.The sample was not returned for evaluation.No additional information was provided related to the reported incident.The condition of the device is not known.A root cause has not been determined.It is not known if the device caused or contributed to the fall.No additional information is available.A sample has not been returned for evaluation however, due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

End user fell while using the device.

• Type of Device: BENCH,BATH,W/ BACK
• 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: 7161987
• MDR Text Key: 96331102
• Report Number: 1417592-2018-00001
• Device Sequence Number: 1
• Product Code: IKX
• 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: Patient
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS89745R
• Device Lot Number: E101253714
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR