MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-10-11 for K-Y WARMING LIQUID manufactured by Personal Products Co..
[311962]
Consumer's spouse reported that 10 minutes after consumer used co's product they developed hives and itching all over, sweating, staggering, swelling of face, closing of throat and loss of consciousness for 10 minutes. Rescue squad was called. Two intravenous catheters were inserted, an electrocardiogram was done, oxygen was administered and epinerphrine was given twice. Consumer was hospitalized overnight and states their diagnosis was anaphylactic shock. This incident occurred during intercourse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2004-00001 |
| MDR Report Key | 548424 |
| Report Source | 04 |
| Date Received | 2004-10-11 |
| Date of Report | 2004-10-11 |
| Date of Event | 2004-05-01 |
| Date Mfgr Received | 2004-09-13 |
| Date Added to Maude | 2004-10-15 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089043708 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y WARMING LIQUID |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | MMS |
| Date Received | 2004-10-11 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 537894 |
| Manufacturer | PERSONAL PRODUCTS CO. |
| Manufacturer Address | 199 GRANDVIEW RD. SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2004-10-11 |