MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED K-Y WARMING JELLY; K-Y JELLY

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

Patient Problems Laceration(s) (1946); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

The case was deemed serious.No further information was available at the time of report.Follow up has been requested to obtain further information.Case assessment for k-y warming jelly 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: not recovered / not resolved. .

Event Description

Case reference number (b)(6) is a spontaneous case report sent by a consumer which refers to a female age unknown.It was reported that two weeks ago on (b)(6) 2019, a female patient of an unknown age had used k-y warming jelly, dose, frequency, indication, route, stop date and duration were all unknown.Patient stated that the she had used the product numerous times with her partner in the past few weeks.Two weeks ago ((b)(6) 2019) when she had used the product, it caused a severe reaction.Patient has been to the doctors twice now, and she would be going back again this week, because the lube caused her to get severe burns and genital lacerations that were being treated with antibiotics and pain medications.Patient stated that she had barely been able to walk due to the extreme pain from this injury and this had affected her ability to attend her college classes and other obligations.Patient stated that the injury was caused from the product, which had been confirmed by her doctor.Patient stated that she had been experiencing extreme pain from her injury for over 2 weeks now (at the time of reporting).At the time of reporting action taken with the suspect product was unknown and outcome of the case was not recovered.Treatment medications: antibiotics and pain medications.Treatment had been reported but it was unclear which events were treated.At the time of the report the effects were ongoing.It was unknown if the patient has any relevant underlying conditions or medical history.The case was deemed serious.No further information was available at the time of report.Follow up has been requested to obtain further information.Case assessment for k-y warming jelly 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.Genital lacerations (injury) [genital injury].Severe burns [genital burning sensation].Extreme pain from injury [pain].Patient had barely been able to walk due to the extreme pain from injury [gait disturbance].Patient's injury had affected the ability to attend their college classes and other obligations [loss of personal independence in daily activities].Batch no.And expiry date: not provided.

• Brand Name: K-Y WARMING JELLY
• Type of Device: K-Y JELLY
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, united kingdom
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, united kingdom HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; 399 interpace parkway; parsippany, NJ 07054-0225 ; 9734042478
• MDR Report Key: 8591110
• MDR Text Key: 144427726
• Report Number: 9610643-2019-00004
• Device Sequence Number: 1
• Product Code: NUC
• UDI-Device Identifier: 00067981089479
• UDI-Public: 00067981089479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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: 04/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other