MAUDE Adverse Event Report: WATER PIK INC. WATER PIK ONTE-TOUCH POWERPULSE MASSAGE DUAL SHOWER SYSTEM; SHOWER HEAD

Model Number XPA-133E/763ME

Device Problem Device Fell (4014)

Patient Problem Easy Bruising (4558)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

Customer stated that they have owned the shower for about 4 months.On (b)(6) 2023, his wife was in the shower and the fixed mount portion popped off causing her to fall in the tub.She sustained bruising and is aching.

• Brand Name: WATER PIK ONTE-TOUCH POWERPULSE MASSAGE DUAL SHOWER SYSTEM
• Type of Device: SHOWER HEAD
• Manufacturer (Section D): WATER PIK INC.; 1730 e prospect rd; fort collins CO
• Manufacturer Contact: jeffrey dornoff ; 1730 e prospect rd; fort collins, CO 80553-0001 ; 9702217062
• MDR Report Key: 16975319
• MDR Text Key: 315711958
• Report Number: 0001712259-2023-00006
• Device Sequence Number: 1
• Product Code: LYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XPA-133E/763ME
• Device Catalogue Number: XPA-133E/763ME
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2022
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White