MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH SAFETY

Model Number	12486
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	No Answer Provided
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is bath safety /shower stool.We are filing this submission in response to mw5104731.This medwatch report incorrectly classifies this as a serious injury.There was no adverse event and no injury sustained.The user has advised that there is a potential design issue we product has not been returned for evaluation.This information is being investigated by the post market surveillance team.
Event or Problem Description
(b)(4) is the initial importer of the device which is bath safety /shower stool.We are filing this submission in response to mw5104731.This medwatch report incorrectly classifies this as a serious injury.There was no adverse event and no injury sustained.The user has advised that there is a potential design issue we product has not been returned for evaluation.This information is being investigated by the post market surveillance team.

• Brand Name: DRIVE
• Common Device Name: BATH SAFETY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12882266
• Report Number: 2438477-2021-00075
• Device Sequence Number: 4827839
• Product Code: ILS
• UDI-Device Identifier: 00822383108902
• UDI-Public: 822383108902
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2021
• Report Date (Section F): 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 12486
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 11/29/2021