MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-09 for LUBRICATING GEL 0F2 manufactured by Perrigo New York, Inc..
[2176459]
This spontaneous report was received from the wife of a (b)(6) male. On (b)(6) 2011, the consumer used an application of lubricating jelly for an unspecified indication and developed itching all over his body, neck and back. He also developed difficulty breathing, a rapid heart rate and his blood pressure dropped. The consumer's wife called 911 and her husband was transported to the hospital. He had no known drug allergies. No further information was provided. Medical confirmation is being sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2434221-2011-00001 |
| MDR Report Key | 2249772 |
| Report Source | 04 |
| Date Received | 2011-09-09 |
| Date of Report | 2011-09-09 |
| Date of Event | 2011-08-15 |
| Date Mfgr Received | 2011-08-16 |
| Date Added to Maude | 2012-06-28 |
| 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, DIRECTOR |
| Manufacturer Street | 515 EASTERN AVENUE |
| 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 | 2011-09-09 |
| Lot Number | 1FT0132 |
| Device Expiration Date | 2013-06-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2011-09-09 |