MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-27 for K-Y YOURS & MINE manufactured by Reckitt Benckiser Healthcare Int. Limited.
[103590634]
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 also states that "this product contains ingredients that may cause skin irritation, especially in persons sensitive to menthol. If irritation or discomfort occurs, discontinue use and consult your health care provider. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[103590635]
Urinary tract infection [urinary tract infection]. While urination there was just a drip or two or nothing at all [urinary retention]. Feeling like patient had to go to urinate [micturition urgency] bladder infection [cystitis]. Burning while urinating [dysuria]. Case description: report no 1, received date: 02-mar-2018. Received from consumer relations, country: united states, (b)(4). Suspect product: ky yours and mine lubricant. Batch no: 1556n1a. Expiry date: 30-sep-2019. (b)(4) is a spontaneous case report sent by an consumer which refers to a female (b)(6). It was reported by patient's boyfriend that on an unspecified date in (b)(6) 2018; his (b)(6) girlfriend started using ky yours and mine lubricant, frequency twice, stop date (b)(6) 2018, route, indication and duration were all unknown. Reporter stated that his girlfriend started using the k-y yours and mine lubricant for the first time 3 weeks before reporting and 3 days after using his girlfriend began to experience burning while urinating and always feeling like she had to go but, when she tried to urinate there was just a drip or two or nothing at all. Reporter stated that she went to the doctor and was treated for a bladder infection. He then stated that the patient tried the k-y yours and mine again about 6 days before reporting and 4 days later she began having the same symptoms. He stated that she spoke with her doctor again and was currently taking the medication her doctor prescribed her. He stated that his girlfriend was on a second round of antibiotics for a urinary tract infection which she had each time they used the product. Patient was feeling much better at the time of reporting. She had no history of urinary tract infections in the past. Patient liked the sensation of the product but, could not use it again due to urinary tract infections. At the time of the report the outcome of the effect was recovering. K-y yours and mine lubricant was de-challenged. K-y yours and mine lubricant was subsequently re-introduced and adverse events reoccurred. The case was deemed serious because it was classed as medically significant due to urinary retention. No further information was available at the time of report. Case assessment for k-y yours and mine lubricant is as follows: the reported serious assessment has not been provided, case relatedness is possible the company's assessment is serious with a relatedness of possible and unlisted. Case outcome: recovering / resolving. Case status: ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010164364-2018-00003 |
| MDR Report Key | 7374456 |
| Report Source | CONSUMER |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-03-02 |
| Date Added to Maude | 2018-03-27 |
| 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 | 2018-03-27 |
| Lot Number | 1556N1A |
| Device Expiration Date | 2019-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-27 |