MAUDE Adverse Event Report: R.POON MEDICAL PRODUCTS (MINGGUANG) COMPANY LIMITE AQUASENSE; BATH SEAT

Model Number	770-525
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bath bench.Product has not been recovered for evaluation.End-user was sitting on the chair in the shower.The back reportedly broke off.She sustained a laceration.No further details are available.We are reporting this event in an overabundance of caution.

• Brand Name: AQUASENSE
• Common Device Name: BATH SEAT
• Manufacturer (Section D): R.POON MEDICAL PRODUCTS (MINGGUANG) COMPANY LIMITE; no.116 qicang road; mingguang anhui, 23940 0; CH 239400
• MDR Report Key: 9716662
• Report Number: 3010865207-2020-00001
• Device Sequence Number: 14283005
• Product Code: ILS
• UDI-Device Identifier: 00754021210336
• UDI-Public: 754021210336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 770-525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/17/2020
• 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: Hospitalization
• Patient Age: 70 YR
• Patient Weight: 68