MAUDE Adverse Event Report: BIBOTING INTERNATIONAL CO., LTD. BIBOTING MASSAGER; MASSAGER, THERAPEUTIC, ELECTRIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Breast Mass (2439); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)

Event Date 11/30/2020

Event Type  Injury  

Event Description

Visit note (b)(6) 2020 hpi: new palpable lesion /bump bilateral breast lump or mass in breast - about a month ago she started using a suction machine creates negative pressure over tissues to, allegedly, increase lymphatic flow and reduce risk of cancers.She used in on her breasts which caused pain and swelling, but she kept using it because the company told her this was normal.Pain and swelling became worse and she stopped using it a week ago.Swelling and pain have since improved.She is worried that she now has breast cancer.Breast exam - 6 cm smooth, round, firm, tender mass over top portion of left breast inferior edge about 2 cm from areola - irregular 4 to 5 cm breast mass in same area of right breast, also firm mammogram (b)(6) 20 impression: right breast: developing asymmetries with breast edema are likely posttraumatic.Probably benign.Bi-rads; recommend diagnostic mammogram and ultrasound in 3 months.In addition, recommend clinical follow up for the site of concern, and management based on clinical findings.Left breast: diffuse breast edema is likely posttraumatic.Probably benign.Bi-rads; recommend breast ultrasound in 3 months.Us (b)(6) 2020 impression: breast us (b)(6) 2020, right breast: developing asymmetries with breast edema are likely posttraumatic; left breast: diffuse breast edema is likely posttraumatic.Fda safety report id#: (b)(4).

• Brand Name: BIBOTING MASSAGER
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): BIBOTING INTERNATIONAL CO., LTD. ; shanghai, cn
• MDR Report Key: 11125208
• MDR Text Key: 225521673
• Report Number: MW5098678
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 51