MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-01 for EXCITE manufactured by Ansell Protective Products, Inc..
[19873944]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018977 |
| MDR Report Key | 1961057 |
| Date Received | 2010-12-01 |
| Date of Report | 2010-11-30 |
| Date of Event | 2010-10-29 |
| Date Added to Maude | 2011-01-21 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXCITE |
| Generic Name | FEMALE STIMULATION GEL 15 MILLILITERS BOTTLE |
| Product Code | MMS |
| Date Received | 2010-12-01 |
| Lot Number | 10048505HC |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL PROTECTIVE PRODUCTS, INC. |
| Manufacturer Address | 200 SCHULZ DRIVE RED BANK NJ 07701 US 07701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-01 |