MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED K-Y YOURS & MINE; LUBRICANT, PERSONAL

Lot Number	114G1A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Bleeding (1888); Vaginal Mucosa Damage (2124)
Date of Event	09/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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: this is a follow-up report required because additional information was received on october 5, 2017 after an initial 30-day alert report was submitted on oct.27, 2017 for report no 1, received date: 02-oct-2017.Received from consumer relations, country: united states, reference no: (b)(4).Suspect product: k-y yours and mine couples lubricant.Batch no 114g1a.Expiry date: 31-jan-2018.Udi no.(b)(4).Case reference number (b)(4) 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 (b)(4), due to same reporter.Report no 2, received date: 05-oct-2017.Received from dso, country: united states, reference no: (b)(4).Information added / updated: patient stated that it was the first use of the product for her and she did not use lubricants.Patient also stated that she was feeling better and did not seek medical care.Patient treated herself at home with ice packs.At the time of the report the effects were improving.It was unknown if the patient had any relevant underlying conditions or medical history.The product batch records have been reviewed.All results were found to be within specification.Rb has made three follow up attempts to contact the consumer.No further information was provided by the consumer.Rb has decided to close the case.The case was deemed serious because it was classed as temporary or permanent functional incapacity and medically significant.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.

• Brand Name: K-Y YOURS & MINE
• Common Device Name: LUBRICANT, PERSONAL
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, hull HU8 7 DS; UK HU8 7DS
• MDR Report Key: 6984838
• Report Number: 3010164364-2017-00006
• Device Sequence Number: 526852
• Product Code: NUC
• UDI-Device Identifier: 67981088922
• UDI-Public: 67981088922
• Combination Product (Y/N): N
• PMA/510(K) Number: K072421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 114G1A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR