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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Respiratory Distress (2045); Swelling (2091); Burning Sensation (2146); Anaphylactoid (2218)

Event Type  Injury  

Manufacturer Narrative

Rb is awaiting for the return of the product for quality analysis and also follow up information regarding the reported incident.The reporter did specify the variety of k-y that was used as jelly lubricant.The reporter did not provide 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 and unanticipated.This section applies only to requirements of the paperwork reduction act of 1995.The public.

Event Description

Case reference number (b)(4) is a spontaneous case report, which refers to a female aged (b)(6) years (date of birth: (b)(6)).It was reported that on an unknown date, a female patient of an unknown age used ky lubricant jelly and lysol, dose, frequency, route, indication, stop date and duration were all unknown.Reporter stated that on an unknown date, she experienced severe respiratory symptoms, severe swelling of airway and patient experienced burning.Suspect product: ky jelly lubricant.Dosing: unknown.Suspect product: lysol unknown.Dosing: unknown.Anaphylaxis reaction (anaphylactic reaction).Severe swelling of airway (respiratory tract oedema) severe respiratory symptoms (respiratory symptom) patient experienced burning (burning sensation) at the time of reporting action taken with the suspect drug and outcome of the case both were unknown.The case was deemed serious because it was classed as medically significant due to respiratory tract oedema and anaphylactic reaction / might have led to death or serious deterioration in health.No further information was available at the time of report.Rb is unable to follow up with the consumer due to lack of contact information.Case assessment for ky lubricant jelly is as follows: the reported serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unanticipated.Case assessment for lysol unknown is as follows: the reported serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unknown.Case outcome: unknown.

Event Description

Case reference number (b)(4) is a spontaneous case report, which refers to a female aged 71 years (date of birth: (b)(6) 1947).It was reported that on an unknown date, a female patient of an unknown age used ky lubricant jelly and lysol, dose, frequency, route, indication, stop date and duration were all unknown.Reporter stated that on an unknown date, she experienced severe respiratory symptoms, severe swelling of airway and patient experienced burning.Suspect product: ky jelly lubricant.Dosing: unknown.Suspect product: lysol unknown.Dosing: unknown.Anaphylaxis reaction [anaphylactic reaction].Severe swelling of airway [respiratory tract oedema].Severe respiratory symptoms [respiratory symptom].Patient experienced burning [burning sensation].At the time of reporting action taken with the suspect drug and outcome of the case both were unknown.The case was deemed serious because it was classed as medically significant due to respiratory tract oedema and anaphylactic reaction / might have led to death or serious deterioration in health.No further information was available at the time of report.Rb is unable to follow up with the consumer due to lack of contact information.Case assessment for ky lubricant jelly is as follows: the reported serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unanticipated.Case assessment for lysol unknown is as follows: the reported serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unknown.Case outcome: unknown.

Manufacturer Narrative

Rb is awaiting for the return of the product for quality analysis and also follow up information regarding the reported incident.The reporter did specify the variety of k-y that was used as jelly lubricant.The reporter did not provide 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 and unanticipated.This section applies only to requirements of the paperwork reduction act of 1995.The public.

• Brand Name: KY PERSONAL LUBRICANT JELLY
• Type of Device: KY JELLY
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• MDR Report Key: 9013871
• MDR Text Key: 161961326
• Report Number: 0009610643-2019-00007
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): Y
• PMA/PMN Number: K810310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR