BATHMATE X30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-22 for BATHMATE X30 manufactured by Dx Product Ltd.

Event Text Entries

[3672105] The pt complained of pain in his penis and adverse swelling. Pt suffers from peyronie's disease and bought a product called bathmate that claimed to cure said disease. The product is also sold under the name of hydromax in the variations of hydromax x40, hydromax x30 and bathmate goliath. Four weeks of the bathmate x30 model. Pt also own the hydromax x40 and bathmate goliath. Dose or amount: 20 min, frequency: day, route: intra. Event abated after use stopped dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5031063
• MDR Report Key: 3249256
• Date Received: 2013-07-22
• Date of Report: 2013-07-22
• Date of Event: 2013-07-20
• Date Added to Maude: 2013-07-29
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BATHMATE
• Generic Name: NONE
• Product Code: LKY
• Date Received: 2013-07-22
• Model Number: X30
• Lot Number: UNK
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DX PRODUCT LTD
• Manufacturer Address: HORACE WALLER VC PARADE SHAW CROSS BUSINESS PK, UNIT 9 WEST YORKSHIRE, DEWSBURYW F127RF UK F12 7RF

Device Sequence Number: 2

• Brand Name: HYDROMAX
• Generic Name: NONE
• Product Code: LKY
• Date Received: 2013-07-22
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DX PRODUCTS LTD
• Manufacturer Address: HORACE WALLER VC PARADE SHAW CROSS BUSINESS PK UNIT 9A WEST YORKSHIRE F127RF UK F12 7RF

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-07-22