MAUDE Adverse Event Report: UZINMEDICARE CO., LTD. SPECTRA S1 PLUS PORTABLE & RECHARGEABLE HOSPITAL STRENGTH DOUBLE ELECTRIC BREAST; PUMP, BREAST, POWERED

Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Target at (b)(6) willingly sold a previously used and returned breast pump (a 5-year-old unit based on the serial number) to me.The corporation does not accept return of any medical device, regardless of the condition.I am stuck with a used pump after paying full price, and have no way of getting a replacement or a refund.

• Brand Name: SPECTRA S1 PLUS PORTABLE & RECHARGEABLE HOSPITAL STRENGTH DOUBLE ELECTRIC BREAST
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): UZINMEDICARE CO., LTD.
• MDR Report Key: 21874146
• Report Number: MW5169343
• Device Sequence Number: 18167187
• Product Code: HGX
• UDI-Device Identifier: 08809108011091
• UDI-Public: 08809108011091
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian