MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT. LIMITED K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL; PERSONAL LUBRICANT

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Rash (2033)
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.Reporter did specify the variety of k-y that was used as k-y touch 2 in 1 massage creme and pleasure gel.The reporter neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.Further information is expected.The company's assessment is serious with a relatedness of possible.
Event or Problem Description
Extreme allergic reaction [hypersensitivity] patient had hard time with breathing.[dyspnoea] slight skin rash [rash].Coughing [cough].Phlegm in lungs [productive cough].Case description: initial report, received date: 14-aug-2018.Received from consumer relations, country: united states, reference no: (b)(4).Medical device: k-y touch 2 in 1 massage creme and pleasure gel.Case reference number us-(b)(6) is a spontaneous case report sent by a consumer which refers to a male age unknown.It was reported by patient's partner that on an unknown date, their husband of an unknown age used k-y touch 2 in 1 massage creme and pleasure gel for an unknown indication.Reporter stated that they recently purchased the product and on an unknown date, patient had an extreme allergic reaction with hard time breathing, coughing, phlegm in his lungs and slight skin rash after using the product.The case was deemed serious because it was classed as medically significant.Follow up has been requested to obtain further information.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: unknown.

• Brand Name: K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL
• Common Device Name: PERSONAL LUBRICANT
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• MDR Report Key: 7820426
• Report Number: 3010164364-2018-00008
• Device Sequence Number: 11084313
• Product Code: NUC
• UDI-Device Identifier: 00067981962161
• UDI-Public: 00067981962161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/27/2018
• 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