MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-02-14 for LUBRICATING GEL 0F2 manufactured by Perrigo New York, Inc..
[3172644]
This spontaneous report was received from the husband of (b)(6) male regarding lubricating gel. On (b)(6) 2013 the consumer used an application for personal lubrication and within 10 mins of application and sexual intercourse he developed an allergic reaction with a burning sensation, welts, rash and swelling of the genital area. The consumer was treated on (b)(6) 2013 in an emergency room with an unspecified steroid injection and another unspecified medication. He was discharged on (b)(6) 2013, after 4-5 hours in the emergency room, with the diagnosis of rash and allergic reaction. He was given orders to take benadryl and an unspecified steroid. The burning sensation and genital swelling resolved on (b)(6) 2013; the rash and allergic reaction resolved on (b)(6) 2013. The consumer reported no known drug allergies. Medical confirmation is being sought. See mfr report 2434221-2013-00002 for a report regarding the consumer's spouse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2434221-2013-00001 |
| MDR Report Key | 2974249 |
| Report Source | 04 |
| Date Received | 2013-02-14 |
| Date of Report | 2013-02-14 |
| Date of Event | 2013-01-20 |
| Date Mfgr Received | 2013-01-22 |
| Date Added to Maude | 2013-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES YOUNG, DIR. |
| Manufacturer Street | 515 E. AVE. |
| Manufacturer City | ALLEGAN MI 49010 |
| Manufacturer Country | US |
| Manufacturer Postal | 49010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUBRICATING GEL 0F2 |
| Generic Name | LUBRICATING JELLY |
| Product Code | KMJ |
| Date Received | 2013-02-14 |
| Lot Number | 2KT0284 |
| Device Expiration Date | 2014-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERRIGO NEW YORK, INC. |
| Manufacturer Address | 1700 BATHGATE AVE. BRONX NY 10457 US 10457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-14 |