MAUDE Adverse Event Report: RECKITT BENCKISER DUREX PLAY MASAJ JELI 2SI1 ARADA UYARICI; LUBRICANT, PERSONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Vaginal Mucosa Damage (2124)

Event Date 11/12/2016

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: DUREX PLAY MASAJ JELI 2SI1 ARADA UYARICI
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): RECKITT BENCKISER; 399 interpace parkway; parsippany NJ 07054
• Manufacturer (Section G): RECKITT BENCKISER; 399 interpace parkway; parsippany NJ 07054
• Manufacturer Contact: joanne martinez ; dansom lane; hull, hull HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 6140010
• MDR Text Key: 61292749
• Report Number: 3010164364-2016-00003
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• PMA/PMN Number: K063385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other