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

Model Number 770-525

Device Problem Material Fragmentation (1261)

Patient Problem Laceration(s) (1946)

Event Date 11/22/2019

Event Type  Injury  

Event 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
• Type of Device: 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: 9501043
• MDR Text Key: 176298300
• Report Number: 2438477-2019-00086
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00754021210336
• UDI-Public: 754021210336
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 770-525
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Distributor Facility Aware Date: 11/22/2019
• Device Age: 24 MO
• Event Location: Home
• Date Report to Manufacturer: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 68