MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE; DENTURE CLEANSER

Lot Number ME021613A

Device Problem Break (1069)

Patient Problem Glaucoma (1875)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident 3 minute.

Event Description

He had poor eye sight from glaucoma / he got glaucoma after he had been using the product.Case description: this case was reported by a consumer and described the occurrence of glaucoma in a (b)(6) male patient who received double salt denture cleanser (polident 3 minute) tablet (batch number (b)(4), expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident 3 minute.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced glaucoma (serious criteria gsk medically significant and other: gsk medically significant) and product complaint.Polident 3 minute was continued with no change.On an unknown date, the outcome of the glaucoma was not recovered/not resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the glaucoma to be related to polident 3 minute.Additional details, the adverse event information was received on 05 january 2017.The consumer reported using the polident 3-minute product for years.He did not had a set start date.The consumer reported that a few of the tablets where broken.The consumer also reported that he had poor eye sight from glaucoma.The consumer stated he got glaucoma after he had been using the product though it had nothing to do with it.He was still using the product.The consumer would send the product back.The lot was (b)(4).

Manufacturer Narrative

This report is associated with argus case (b)(4), polident 3 minute.Qa results: qa results received on (b)(6) 2017, formal report created on 06 june 2017.A complaint sample was not obtained from the consumer.Therefore, a complaint sample evaluation was not able to be performed as part of the investigation.All batch documentation, in process checks and product release testing conform to specifications.A retention sample evaluation was performed.There was no observable evidence of nonconformance to specifications for the examined representative product samples in regard to broken tablets or seal issues indicating broken tablets during packaging process.Without evidence of the presenting defect, this complaint is unsubstantiated.

Event Description

Case description: this case was reported by a consumer and described the occurrence of glaucoma in a (b)(6) male patient who received double salt denture cleanser (polident 3 minute) tablet (batch number me021613a, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident 3 minute.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced glaucoma (serious criteria gsk medically significant and other: gsk medically significant) and product complaint.Polident 3 minute was continued with no change.On an unknown date, the outcome of the glaucoma was not recovered/not resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the glaucoma to be related to polident 3 minute.Additional details, the adverse event information was received on 05 january 2017.The consumer reported using the polident 3-minute product for years.He did not had a set start date.The consumer reported that a few of the tablets where broken.The consumer also reported that he had poor eye sight from glaucoma.The consumer stated he got glaucoma after he had been using the product though it had nothing to do with it.He was still using the product.The consumer would send the product back.The lot was me021613a.Follow-up information was received on 04 march 2017 from the quality assurance (qa) department regarding complaint number (b)(4) for batch number me021613a.According to the investigation, no sample was received.There had been (b)(4) broken tablets complaints since the packaging of this lot and this was the only one for this lot.A retention sample was evaluated and it did not contain any broken tablets.It was unable to control the storage or handling of the product once it leaved the site.No issues noted in the batch file.Final justification was noted as unable to substantiated the claim.Follow up information was received on 06 june 2017 (non-significant) from the quality assurance (qa) department regarding complaint number (b)(4) for batch number me021613a.No significant information was provided compared to the follow up qa investigation received on 04 march 2017, except for the information now being provided in a final qa investigation report for reporting purposes.

• Brand Name: POLIDENT 3 MINUTE
• 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: 6250809
• MDR Text Key: 64910741
• Report Number: 1020379-2017-00001
• 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
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ME021613A
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 63 YR