EXCITE
Received Dec 1, 2010 · Event occurred Oct 29, 2010
Report MW5018977 · MDR key 1961057
Device
Generic name
Female Stimulation Gel 15 Milliliters Bottle
Manufacturer
Ansell Protective Products, Inc.Lot number
10048505HC
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Bacterial Infection
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Staphylococcus Aureus
- Swelling
Narrative
Description of Event or Problem
MS. (B)(6) STATES THAT SHE WAS DIAGNOSED AS HAVING A SEVERE ALLERGIC REACTION TO THE REFERENCED PRODUCT. MS. (B)(6) STATES THAT THE 1ST SYMPTOM TO DEVELOP WAS ITCHING IN HER GENITAL AREA. MS. (B)(6) STATES THAT APPROX 24 HRS LATER HER GENITALS WERE SWOLLEN AND BLISTERED TO THE EXTENT THAT SHE HAD TO BE CATHETERIZED. MS. (B)(6) STATES THAT SHE WAS ALSO DIAGNOSED AS HAVING A (B)(6) INFECTION WHICH BEGAN AS A RESULT OF THE ALLERGIC REACTION. MS. (B)(6) STATES THAT THIS IS THE FIRST TIME THIS PRODUCT HAS BEEN USED. MS. (B)(6) STATES HOWEVER, THAT ANOTHER BRAND PRODUCT HAS PREVIOUSLY BEEN USED WITHOUT ANY PROBLEMS. HEALTH CARE PROFESSIONAL: (B)(6). PURCHASE DATE: (B)(6) 2010. RETAIL: (B)(6).