MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-07 for K-Y WARMING LIQUID manufactured by Reckitt Benckiser Healthcare Int Limited.
[66721428]
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 irritation. If irritation or discomfort occurs, discontinue use and consult a doctor. This product is not a contraceptive and does not contain a spermicide. Keep out of reach of children and away from eyes and ears. Do not use if quality seal on opening is broken or missing". The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[66721429]
Case description: report no 1, received date: 31-jan-2017. Received from consumer relations, country: united states, reference no: (b)(4). Suspect product: ky warming liquid. Batch no: 1442k1. Expiry date: 30-oct-2018. Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a male aged (b)(6) years. It was reported that on (b)(6) 2017 (thursday), a (b)(6) year old male patient applied ky warming liquid (half bottle) to his penis during sex for the first time, frequency single, stop date (b)(6) 2017 and duration was 1 day. He stated that within 2-3 minutes on (b)(6) 2017, he felt a burning sensation. He did not stop and continued to have sex through the discomfort. He stated that his penis was red and it looked like the skin had been ripped off the head and shaft. His fianc? Did apply neosporin and it had no effect. He would be seeking medical attention on (b)(6) 2017. He denied any known allergies. After application, the shaft of his penis was burning. He continued having sexual relations and the area was getting hotter and hotter. He said there was no skin on the shaft of his penis. He said that this had ruined his life. He went to the emergency room on (b)(6) 2017 and was diagnosed with a chemical burn and given a burn cream. At the time of the report the effects was unknown and his appointment scheduled to see his hcp was not provided. It was unknown if the patient has any relevant underlying conditions or medical history. The case was deemed serious because it was classed as medically significant due to skin exfoliation. No further information was available at the time of report. Case assessment for ky warming liquid is as follows: the reported serious assessment has not been provided, case relatedness is possible / likely. The company's assessment for the case is serious with a relatedness of possible/likely and unanticipated/unlisted. Case outcome: unknown. Case status: ongoing. Case comment: reports assessment: diagnosis: chemical burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010164364-2017-00003 |
| MDR Report Key | 6308648 |
| Report Source | CONSUMER |
| Date Received | 2017-02-07 |
| Date of Report | 2017-01-31 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2017-02-07 |
| 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, UNITED KINGDOM HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer Phone | 4042478 |
| 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 WARMING LIQUID |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-02-07 |
| Lot Number | 1442K1 |
| Device Expiration Date | 2018-10-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-07 |