MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-04-23 for POLIDENT RETAINER CLEANSER manufactured by Block Drug Co., Inc..
[142765467]
Argus case id (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142765468]
Numbness of tongue and right side of the mouth. [hypoesthesia oral], accidental swallowing of the product. [accidental device ingestion]. This case was reported by a consumer via call center representative and described the occurrence of hypoesthesia oral in a (b)(6) female patient who received denture cleanser (polident retainer cleanser) tablet (batch number 186192rg, expiry date 30th june 2021) for denture wearer. On (b)(6) 2019, the patient started polident retainer cleanser. On (b)(6) 2019, 10 min after starting polident retainer cleanser, the patient experienced hypoesthesia oral and accidental device ingestion (serious criteria gsk medically significant). The action taken with polident retainer cleanser was unknown. On an unknown date, the outcome of the hypoesthesia oral and accidental device ingestion were not recovered/not resolved. It was unknown if the reporter considered the hypoesthesia oral and accidental device ingestion to be related to polident retainer cleanser. Additional details: the patient accidentally drank two gulps of a solution of water and one tablet of polident retainer effervescent tablet 32 tablets, because she thought it was a glass of water. The patient stated that about 15 minutes later her tongue and the right side of her mouth were started feeling numb. The lot number provided by consumer was 186192rg. It might actually be 18c192rg or 18g192rg which would better correspond to the right lot format for polident tablets. This case is being resubmitted to capture error correction as per information received on (b)(6) 2019: this case was associated with device and was accordingly processed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00023 |
| MDR Report Key | 8539816 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-04-23 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK, |
| Manufacturer City | NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT RETAINER CLEANSER |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-04-23 |
| Lot Number | 186192RG |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLOCK DRUG CO., INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-23 |