MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for DUREX PLAY MASAJ JELI 2SI1 ARADA UYARICI manufactured by Reckitt Benckiser.
[61292749]
Case description: report no 1, received date: 14-nov-2016. Received from consumer relations, country: (b)(6), (b)(4). Case (b)(4) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported by patient's husband that on (b)(6) 2016 (2 days before reporting) he and his wife age unknown used durex 2 in 1 aloe vera massage gel. He said his wife vagina's has burned sensitivity during intercourse, the effect of lubricant was weak so they used several times in short time during intercourse. After that there had been burn sensitivity unbearable. She had been to hospital to stop burn feeling. She had given a transfusion, and she had given an injection of an analgesic. She stayed in hospital under surveillance. He said they had been using that same product previously, there was no side effect. The doctor made some tests and any abnormal issue were not found. The patient was admitted to hospital, admittance date (b)(6) 2016, discharge date and days in hospital were all unknown. At the time of the report the effects was unknown and patient had visited the doctor. It was unknown if the patient has any relevant underlying conditions or medical history. The case was deemed serious because of hospitalization. No further information was available at the time of report. Case assessment for durex 2 in 1 aloe vera massage gel is as follows: the reported serious assessment has not been provided, case relatedness is likely. The company's assessment for the case is serious with a relatedness of likely and unanticipated. Case outcome: unknown. Case status: ongoing.
Patient Sequence No: 1, Text Type: D, B5
[67450720]
The reporter did specify the variety of durex that was used as durex 2 in 1 aloe vera massage gel on follow-up. The reporter neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis despite follow-up being made with the reporter. Therefore, the company is unable to conduct any further investigation at this moment in time. The product labelling also states "suitable for vaginal, anal and oral sex. Avoid contact with eyes. If you experience irritation, stop using this lubricant. Store in a cool dry place away from direct sunlight. Use within three months of opening. Keep out of reach of children. " the company's assessment for the case is serious with a relatedness of conditional and unlisted.
Patient Sequence No: 1, Text Type: N, H10
[67450721]
Case description: report no 1, received date: 14-nov-2016. Received from consumer relations, country: (b)(6). (b)(4). Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported by patient's husband that on (b)(6) 2016 (2 days before reporting) he and his wife age unknown used durex 2 in 1 aloe vera massage gel. He said his wife's vagina has "burn sensitivity" during intercourse, the effect of lubricant was weak so they used several times in short time during intercourse. After that there had been "burn sensitivity unbearable. " she had been to hospital to stop "burn feeling. " she had given a transfusion, and she had given an injection of an analgesic. She stayed in hospital under surveillance. He said they had been using that same product previously, there was no side effect. The doctor made some tests and any abnormal issue were not found. The patient was admitted to hospital, admittance date (b)(6) 2016, discharge date and days in hospital were all unknown. At the time of the report, the effects was unknown and patient had visited the doctor. It was unknown if the patient has any relevant underlying conditions or medical history. The case was deemed serious because of hospitalization. No further information was available at the time of report. Case assessment for durex 2 in 1 aloe vera massage gel 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 unlisted. Case outcome: unknown. Case status: ongoing. Final report, received date: 01-feb-2017. Received from country: (b)(6), reference no: (b)(4). The (b)(4) contacted the reporter for further information. The reporter explained that his wife, the patient, went to see a hcp; the hcp did some blood tests and serum was given to the patient. He confirmed that the patient was not hospitalised, and has now recovered. The product was not returned for analysis and batch numbers were not provided. No factory investigations were, therefore, completed. Please see risk assessment report attached: medical evaluation: durex 2 in 1 aloe vera massage gel. Rb has decided to close the case. The company's assessment for the case is serious with a relatedness of conditional and unlisted. Case outcome: recovered/resolved. Case status: closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010164364-2016-00003 |
| MDR Report Key | 6140010 |
| Date Received | 2016-12-01 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-11-12 |
| Date Mfgr Received | 2016-11-14 |
| Date Added to Maude | 2016-12-01 |
| 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 | JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HULL HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer G1 | RECKITT BENCKISER |
| Manufacturer Street | 399 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUREX PLAY MASAJ JELI 2SI1 ARADA UYARICI |
| Generic Name | LUBRICANT, PERSONAL |
| Product Code | NUC |
| Date Received | 2016-12-01 |
| 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 |
| Manufacturer Address | 399 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-12-01 |