MAUDE Adverse Event Report: GEODIS LOGISTICS LANSINOH 2.0 DOUBLE BREAST PUMP; PUMP, BREAST, NON-POWERED

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

Patient Problems Skin Tears (2516); Breast Discomfort/Pain (4504)

Event Date 12/26/2020

Event Type  Injury  

Event Description

Damage to breast tissue.Attached product to nipple used product for 20 minutes.Removed product as directed, noticed torn skin around right nipple with pain.

• Brand Name: LANSINOH 2.0 DOUBLE BREAST PUMP
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section D): GEODIS LOGISTICS
• MDR Report Key: 11093602
• MDR Text Key: 224532885
• Report Number: MW5098558
• Device Sequence Number: 1
• Product Code: HGY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 113