MAUDE Adverse Event Report: PHARMATECH AS PTI ROYSTON LLC POLIDENT DENTURE CLEANSER

Lot Number 18G204RGC

Device Problem Product Quality Problem (1506)

Patient Problem Bronchitis (1752)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Bronchitis [bronchitis], product complaint [product complaint].Case description: this case was reported by a consumer via call center representative and described the occurrence of bronchitis in a male patient who received denture cleanser (polident denture cleanser) tablet (batch number 18g204rgc, expiry date 30th june 2021) and (batch number p19031601, expiry date 30th june 2021) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, the dose was changed to an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced bronchitis (serious criteria hospitalization) and product complaint.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the bronchitis and product complaint were unknown.It was unknown if the reporter considered the bronchitis to be related to polident denture cleanser.Additional details, initial and follow 1, 2 and 3 were processed together.Consumer called to follow up pqc case- (b)(6) sample test results indicated that he may be hospitalized for more than ten days due to bronchitis next monday ((b)(6)), and follow-up results can call his son.Subsequently, consumer said that he always bought a box of polident denture cleanser tablets every year.Because polident denture cleanser for full tablets bought this year(30 pieces) the packaging and cleanser tablets are not the same as before and then this box of polident denture cleanser for full tablets had been mailed to our company for testing, and no subsequent purchase and use of polident cleanser tablets.18g204rgc is the primary package lot number and p19031601 is the secondary package lot number.The follow up information was received from qa department on 16 mar 2020.The complaint remains unconfirmed.It is not known how the product is handled or stored once it ships from the pti facility.Product meet all specification at the time of release.The follow up information was received from qa department on 17 mar 2020.Consumer placed a tablet in the warm water but only little bubbles came out (on the surface of water, the solution also didn't change to green as usual.Used one tablet after bought on (b)(6) effervescence is reduced a lot, only a little bit bubble.Confirm that there is no abnormality in the production process, the product is qualified for release, and there is no abnormality in the sample inspection.The complaint conclusion will be unsubstantiated.The follow up information was received on 17 mar 2020.The consumer said that he is still hospitalized.This report is resubmitted to capture correction and the information was received on 13 mar 2020.The manufacturer for suspect product was captured correctly with pharma tech ind.(initially it was wrongly reported as pti not block drug) and the pqc information was captured correctly in m/w info section.

Manufacturer Narrative

Argus case (b)(4).

Event Description

Bronchitis [bronchitis].Case description: this case was reported by a consumer via call center representative and described the occurrence of bronchitis in a male patient who received denture cleanser (polident denture cleanser) tablet (batch number 18g204rgc, expiry date 30th june 2021) and (batch number p19031601, expiry date 30th june 2021) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, the dose was changed to an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced bronchitis (serious criteria hospitalization) and product complaint.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the bronchitis and product complaint were unknown.It was unknown if the reporter considered the bronchitis to be related to polident denture cleanser.Additional details, initial and follow 1, 2 and 3 were processed together.Consumer called to follow up pqc case- (b)(4) sample test results indicated that he may be hospitalized for more than ten days due to bronchitis next monday ((b)(6)), and follow-up results can call his son.Subsequently, consumer said that he always bought a box of polident denture cleanser tablets every year.Because polident denture cleanser for full tablets bought this year(30 pieces) the packaging and cleanser tablets are not the same as before and then this box of polident denture cleanser for full tablets had been mailed to our company for testing, and no subsequent purchase and use of polident cleanser tablets.18g204rgc is the primary package lot number and p19031601 is the secondary package lot number.The follow up information was received from qa department on 16 mar 2020.The complaint remains unconfirmed.It is not known how the product is handled or stored once it ships from the pti facility.Product meet all specification at the time of release.The follow up information was received from qa department on 17 mar 2020.Consumer placed a tablet in the warm water but only little bubbles came out( on the surface of water, the solution also didn't change to green as usual.Used one tablet after bought on (b)(6).Effervescence is reduced a lot, only a little bit bubble.Confirm that there is no abnormality in the production process, the product is qualified for release, and there is no abnormality in the sample inspection.The complaint conclusion will be unsubstantiated.The follow up information was received on 17 mar 2020.The consumer said that he is still hospitalized.This report is resubmitted to capture correction and the information was received on 13 mar 2020.The manufacturer for suspect product was captured correctly with pharma tech ind.(initially it was wrongly reported as pti not block drug) and the pqc information was captured correctly in m/w info section.The follow up information was received on 08 apr 2020.Consumer stated that he has discharged for 2 days.

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): PHARMATECH AS PTI ROYSTON LLC; royston, ga
• MDR Report Key: 9949024
• MDR Text Key: 194032225
• Report Number: 3005372036-2020-00001
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2021
• Device Lot Number: 18G204RGC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization