MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED KY LUBRICANT JELLY; KY JELLY

Lot Number 9010K1

Device Problems Use of Device Problem (1670); Device Contamination with Chemical or Other Material (2944)

Patient Problems Skin Erosion (2075); Vaginal Mucosa Damage (2124); Foreign Body In Patient (2687)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

No action considered necessary for this incident at this point, the company are currently waiting for 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 company's assessment is serious with relatedness of possible.

Event Description

Case reference number (b)(6) is a spontaneous case report sent by a consumer which refers to a female aged (b)(6) years.It was reported that on (b)(6) 2019, a (b)(6)-year-old female patient used k-y personal lubricant jelly, stop date (b)(6) 2019, dose, frequency, route, indication and duration were all unknown.Patient stated that on (b)(6) 2019, she had purchased and used the product and it had a metal part inside the lubricant, which cut her on the inside of her vaginal area.She stated that she did go to the hospital and was treated for scrapped skin.She reported that she was given antibiotics amoxicillin.She also stated that she had received a few stitches.She said that she did not have the product nor the object found in the tube.She stated that she threw the product away in a panic.At the time of report, action taken with the suspect product was withdrawn and case outcome was unknown.Usage/application details: unknown.At the time of the report the effect was unknown.It was unknown if the patient had any relevant underlying conditions or medical history.The case was deemed serious due to a condition necessitating medical or surgical intervention.No further information was available at the time of report.Follow up has been requested to obtain further information.Case assessment for k-y personal lubricant jelly is as follows: the reported serious assessment has not been provided; case relatedness is possible / likely.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: unknown.Case status: ongoing.

• Brand Name: KY LUBRICANT JELLY
• Type of Device: KY JELLY
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lane; hull, HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 9136804
• MDR Text Key: 166556151
• Report Number: 0009610643-2019-00008
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• PMA/PMN Number: K810310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/30/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Lot Number: 9010K1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR