MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER (UNKNOWN)

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

Patient Problem Fever (1858)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pyrexia [pyrexia] case description: this case was reported by a consumer via call center representative and described the occurrence of pyrexia in a male patient who received denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started polident denture cleanser (unknown).On an unknown date, an unknown time after starting polident denture cleanser (unknown), the patient experienced pyrexia (serious criteria hospitalization).The action taken with polident denture cleanser (unknown) was unknown.On an unknown date, the outcome of the pyrexia was unknown.It was unknown if the reporter considered the pyrexia to be related to polident denture cleanser (unknown).[clinical course] on an unknown date, the patient had used polident denture cleanser (unknown) for a long time.Pyrexia (serious criteria hospitalization) of 38 degrees celsius persisted for a week, and he was told to admit to a hospital.No further information is expected.

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park,, NC 27709 ; 8888255249
• MDR Report Key: 12860603
• MDR Text Key: 285836345
• Report Number: 1020379-2021-00063
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2021
• 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): Hospitalization
• Patient Sex: Male