MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-27 for K-Y YOURS & MINE manufactured by Reckitt Benckiser Healthcare Int Limited.
[90479699]
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident. Upon reporting the incident, the consumer was able to provide details of the product name, batch number and expiry date, therefore enabling rb to review the process records and release testing results from the point of initial manufacture and check retained samples for the specific batch identified. The product labelling states that "this product contains ingredients that may cause skin irritation, especially in person sensitive to menthol. If irritation or discomfort occurs, discontinue use and consult your health care provider. This product is not a contraceptive and does not contain a spermicide. Keep out of reach of children. " the company's assessment for this case is serious and possible.
Patient Sequence No: 1, Text Type: N, H10
[90479700]
Patient's blisters and sores opened up and started to bleed [haemorrhage] patient developed blister on private area [genital blister] patient had sores on her private area [genital pain]. Case description: report no 1 received from consumer relations, country: united states. Suspect product: k-y yours and mine couples lubricant. Batch no 114g1a. Expiry date: 31-jan-2018. (b)(4). Case is a spontaneous case report sent by a consumer which refers to a female aged (b)(6). It was reported that on (b)(6) 2017, a (b)(6) female patient bought and used k-y yours and mine couples lubricant; route, indication and duration were all unknown. She reported that on (b)(6) 2017, she developed sores and blister on her private area. Patient stated that blisters and sores opened up and started to bleed. She stated that this was the first and only time using the product and that she would no longer use it. Patient stated that she did not seek any medical attention regarding the reactions she had. Patient also stated that she tried to use ice and aloe to treat the affected area. Patient stated that it had not cleared up at the time of reporting, but it had started to do so and the bleeding and pain had also started to go away. She stated that when the reaction first took place, it was very painful to the point where she would cry. At the time of the report the effects were recovering. It was unknown if the patient had any relevant underlying conditions or medical history. The case was deemed serious because it was classed as temporary or permanent functional incapacity and medically significant. No further information was available at the time of report. Case assessment for k-y yours and mine couples lubricant 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: recovering / resolving. Case status: ongoing. This case is linked to us-rb-096256-17, due to same reporter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010164364-2017-00006 |
| MDR Report Key | 6984838 |
| Report Source | CONSUMER |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-10-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, 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 YOURS & MINE |
| Generic Name | LUBRICANT, PERSONAL |
| Product Code | NUC |
| Date Received | 2017-10-27 |
| Lot Number | 114G1A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HULL HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-27 |