MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-08 for K-Y WARMING JELLY manufactured by Reckitt Benckiser Healthcare Int Limited.
[144427726]
The case was deemed serious. No further information was available at the time of report. Follow up has been requested to obtain further information. Case assessment for k-y warming jelly is as follows: the reported serious assessment has not been provided, case relatedness is possible. The company's assessment for the case is serious with a relatedness of possible and unanticipated. Case outcome: not recovered / not resolved.?
Patient Sequence No: 1, Text Type: N, H10
[144427727]
Case reference number (b)(6) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported that two weeks ago on (b)(6) 2019, a female patient of an unknown age had used k-y warming jelly, dose, frequency, indication, route, stop date and duration were all unknown. Patient stated that the she had used the product numerous times with her partner in the past few weeks. Two weeks ago ((b)(6) 2019) when she had used the product, it caused a severe reaction. Patient has been to the doctors twice now, and she would be going back again this week, because the lube caused her to get severe burns and genital lacerations that were being treated with antibiotics and pain medications. Patient stated that she had barely been able to walk due to the extreme pain from this injury and this had affected her ability to attend her college classes and other obligations. Patient stated that the injury was caused from the product, which had been confirmed by her doctor. Patient stated that she had been experiencing extreme pain from her injury for over 2 weeks now (at the time of reporting). At the time of reporting action taken with the suspect product was unknown and outcome of the case was not recovered. Treatment medications: antibiotics and pain medications. Treatment had been reported but it was unclear which events were treated. At the time of the report the effects were ongoing. It was unknown if the patient has any relevant underlying conditions or medical history. The case was deemed serious. No further information was available at the time of report. Follow up has been requested to obtain further information. Case assessment for k-y warming jelly is as follows: the reported serious assessment has not been provided, case relatedness is possible. The company's assessment for the case is serious with a relatedness of possible and unanticipated. Genital lacerations (injury) [genital injury]. Severe burns [genital burning sensation]. Extreme pain from injury [pain]. Patient had barely been able to walk due to the extreme pain from injury [gait disturbance]. Patient's injury had affected the ability to attend their college classes and other obligations [loss of personal independence in daily activities]. Batch no. And expiry date: not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610643-2019-00004 |
| MDR Report Key | 8591110 |
| Report Source | CONSUMER |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-05-08 |
| 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 | 3 |
| Manufacturer Contact | JOANNE MARTINEZ |
| Manufacturer Street | 399 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 070540225 |
| Manufacturer Country | US |
| Manufacturer Postal | 070540225 |
| Manufacturer Phone | 9734042478 |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, UNITED KINGDOM HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU8 7DS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y WARMING JELLY |
| Generic Name | K-Y JELLY |
| Product Code | NUC |
| Date Received | 2019-05-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT LIMITED |
| Manufacturer Address | DANSOM LANE HULL, UNITED KINGDOM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-08 |