LANSINOH AFFINITY BREAST PUMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-06 for LANSINOH AFFINITY BREAST PUMP manufactured by Lansinoh.

Event Text Entries

[3116854] This mfr seems to lack basic systems to log capa's in properly. The company in question is lansinoh. This product has serious issues and needs to be investigated. The company also labels devices saying they can not be returned which limits the capa's that come in to the company. There are thousands of these reports on the internet. I suspect there may be over 10,000 defective products in circulation. Events include: doesn't empty breast and also hurts. Good while it lasts. Cups too small for me and despite the suction being terrible it still leaving me sore after use. It doesn't have the same suction as the older model and i get half the milk that i get from the medela symphony. The purple soft plastic edge seals on my breast and when i am done pumping, it feels like i am peeling on my skin when i remove them. Poor suction and durability. Disappointed. It doesn't pump. Lasted half a day. Suction is not strong enough. 2. 0 out of 5 stars worth what you pay. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5026810
• MDR Report Key: 2732818
• Date Received: 2012-09-06
• Date of Report: 2012-03-28
• Date Added to Maude: 2012-09-10
• 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: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LANSINOH AFFINITY BREAST PUMP
• Generic Name: BREAST PUMP
• Product Code: HGY
• Date Received: 2012-09-06
• Operator: LAY USER/PATIENT
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LANSINOH

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-06