MAUDE Adverse Event Report: PROCTER & GAMBLE MFG. GMBH KUKIDENTDENTURECAREDENTUREADHESIVE; ADHESIVE, DENTURE - KOO

Device Problem Insufficient Information (3190)

Patient Problems Airway Obstruction (1699); Myocardial Infarction (1969); Decreased Respiratory Rate (2485); Foreign Body In Patient (2687); Respiratory Arrest (4461)

Event Date 03/08/2023

Event Type  Death  

Manufacturer Narrative

Product return was requested or its in transport.Evaluation will occur upon receipt of product return.

Event Description

Respiratory arrest [respiratory arrest] heart attack [myocardial infarction] episode of bradypnea [bradypnoea] obstruction of airway [obstructive airways disorder] (obstruction of airway) with a substance compatible with dental prosthesis glue [foreign body in respiratory tract] case narrative: the following case was received via e-mail from a regulatory authority (infarmed - national authority of medicines/health products, 1317/2023) on (b)(6) 2023: a hospital (unspecified healthcare professional) reported that a patient, 92 year-old male, used kukident denture care denture adhesive, beginning on an unspecified date.The patient, who was hospitalized, experienced a sudden episode of bradypnea that evolved with respiratory arrest and heart attack, all beginning on (b)(6) 2023.During an attempt to perform orotracheal intubation, the (medical) team found an obstruction of the airway (b)(6) 2023) with a substance compatible with dental prosthesis glue.Relevant history: none reported.Concomitant product(s): none reported.It was unspecified if the consumer previously used the same version of the device.Relevant history: none reported.The event and case outcome were fatal.No further information was provided.

• Brand Name: KUKIDENTDENTURECAREDENTUREADHESIVE
• Type of Device: ADHESIVE, DENTURE - KOO
• Manufacturer (Section D): PROCTER & GAMBLE MFG. GMBH; h. - s. richardson strasse; gross-gerau 64521 ; GM 64521
• Manufacturer (Section G): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 17331862
• MDR Text Key: 319103215
• Report Number: 9617667-2023-00001
• Device Sequence Number: 1
• Product Code: KOO
• Combination Product (y/n): Y
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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
• 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): Death
• Patient Age: 92 YR
• Patient Sex: Male