FDA Adverse Event Injury Summary report: N

LIFESTYLES WARM LOVIN'

MDR report key: 4309889 · Received October 14, 2014

Report

Report Number
1019632-2014-00015
Event Type
Injury
Date Received
October 14, 2014
Report Date
October 14, 2014
Manufacturer
IDS MFG LIMITED
Product Code
NUC
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
KY, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4).

Description of Event or Problem · 1

THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES PERSONAL LUBRICANT HE EXPERIENCED A SEVERE ALLERGIC REACTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
651457 LIFESTYLES WARM LOVIN' PERSONAL LUBRICANT NUC IDS MFG LIMITED 11120605DR

Patients

Seq Age Sex Outcome Treatment
1 Other