LATEX NIPPLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-19 for LATEX NIPPLE * manufactured by Playtex Products, Inc..

Event Text Entries

[145546] Angioedema from latex nipple. Various outbreaks to latex. Multiple food allergies (apple, banana, grape, orange, cinnamon, mayo, maple syrup, salad dressings). Frequent outbreaks of hives past week.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017994
• MDR Report Key: 260421
• Date Received: 2000-01-19
• Date of Report: 1999-11-23
• Date of Event: 1997-03-01
• Date Added to Maude: 2000-02-02
• 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: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LATEX NIPPLE
• Generic Name: *
• Product Code: FNN
• Date Received: 2000-01-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 252223
• Manufacturer: PLAYTEX PRODUCTS, INC.
• Manufacturer Address: 804 WALKER RD. DOVER DE 19904 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-01-19