MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-03-07 for K-Y WARMING LIQUID manufactured by Personal Products Co..
[378764]
Consumer info center notified via internet from j&j affiliate that consumer rang up to say that during december while they were pregnant they had used a sample of k-y warming liquid which company had sent to them. They said that after using the product during intercourse they experienced a burning sensation and later that night had started to bleed. Three days later they had a miscarriage. Rep asked if their doctor had been able to give an opinion as to why they had miscarried and they said that the drs were unable to give a specific reason. They said that they are convinced that the k-y warming liquid had caused the miscarriage and they were determined to go public and inform everyone that this product should not be used during pregnancy. They said that it had taken them sometime to contact co as they still had difficulty in accepting the loss of their baby. They ended the conversation by saying they would wait to hear from the company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2005-00001 |
| MDR Report Key | 580399 |
| Report Source | 04 |
| Date Received | 2005-03-07 |
| Date of Event | 2004-12-01 |
| Date Mfgr Received | 2005-02-09 |
| Date Added to Maude | 2005-03-14 |
| 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 | 2005-03-07 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 570245 |
| Manufacturer | PERSONAL PRODUCTS CO. |
| Manufacturer Address | 199 GRANDVIEW RD. SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-07 |