MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED); DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Aspiration/Inhalation (1725); Fever (1858)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), (b)(6) polident for partials (polident for partials with taed).(b)(6) polident for partials (polident for partials with taed) is marketed as polident tablets in the us.

Event Description

Aspiration.Pyrexia.Case description: this case was reported by a pharmacist via call center representative and described the occurrence of aspiration in a (b)(6) male patient who received double salt denture cleanser ((b)(6) polident for partials (polident for partials with taed)) tablet for an unknown indication.Concurrent medical conditions included hospitalisation and bedridden.On an unknown date, the patient started (b)(6) polident for partials (polident for partials with taed).On (b)(6) 2017, 0 min after starting (b)(6) polident for partials (polident for partials with taed), the patient experienced aspiration (serious criteria gsk medically significant), pyrexia and accidental ingestion of product.The action taken with (b)(6) polident for partials (polident for partials with taed) was unknown.In (b)(6) 2017, the outcome of the aspiration and pyrexia were recovered/resolved.On an unknown date, the outcome of the accidental ingestion of product was unknown.It was unknown if the reporter considered the aspiration and pyrexia to be related to (b)(6) polident for partials (polident for partials with taed).[clinical course] on (b)(6) 2017, it was not certain but a while ago, a bed-ridden inpatient may have ingested two tablets of (b)(6) polident for partials (polident for partials with taed).Although it was unknown whether this episode was the cause, he had slight fever as of the report and might have also developed aspiration since he was bed-ridden.Follow-up information received from the reporting pharmacist on 14 february 2017.[clinical course] it was confirmed that the patient became afebrile immediately after accidental ingestion of (b)(6) polident for partials (polident for partials with taed), resumed taking meals, and recovered.

Manufacturer Narrative

This report is associated with argus (b)(4), (b)(6) polident for partials (polident for partials with taed).(b)(6) polident for partials (polident for partials with taed) is marketed as polident tablets in the us.

Event Description

Pyrexia.] case description: this case was reported by a pharmacist via call center representative and described the occurrence of pyrexia in a (b)(6) male patient who received double salt denture cleanser ((b)(6) polident for partials (polident for partials with taed)) tablet for an unknown indication.Concurrent medical conditions included hospitalisation and bedridden.On (b)(6) 2017, the patient started (b)(6) polident for partials (polident for partials with taed) (oral) 2 dosage form(s) single dose (2 dosage form(s) daily).On (b)(6) 2017, 0 min after starting (b)(6) polident for partials (polident for partials with taed), the patient experienced pyrexia and accidental ingestion of product.The action taken with (b)(6) polident for partials (polident for partials with taed) was unknown.In (b)(6) 2017, the outcome of the pyrexia was recovered/resolved.On an unknown date, the outcome of the accidental ingestion of product was unknown.It was unknown if the reporter considered the pyrexia to be related to (b)(6) polident for partials (polident for partials with taed).[clinical course] on (b)(6) 2017, it was not certain but a while ago, a bed-ridden inpatient may have ingested two tablets of (b)(6) polident for partials (polident for partials with taed).Although it was unknown whether this episode was the cause, he had slight fever as of the report and might have also developed aspiration since he was bed-ridden.Follow-up information received from the reporting pharmacist on 14 february 2017.[clinical course] it was confirmed that the patient became afebrile immediately after accidental ingestion of (b)(6) polident for partials (polident for partials with taed), resumed taking meals, and recovered.Previous report was accidentally submitted without containing follow-up information.Follow-up information received from the reporting pharmacist on 21 february 2017 [clinical course] it was confirmed that no aspiration developed and the patient recovered quickly.Comment: *downgrade report*.

• Brand Name: JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6347713
• MDR Text Key: 67934636
• Report Number: 1020379-2017-00021
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

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: No Information
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• 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: 89 YR