MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-07-30 for POLIDENT DENTURE CLEANSER TABLETS manufactured by Glaxosmithkline.
[17150698]
This case was reported by a consumer and described the occurrence of urinary tract infection in a (b)(6) female patient who received two variants or double salt denture cleanser (polident denture cleanser tablets and polident overnight denture cleanser tablets) for dentures. A physician or other health care professional has not verified this report. The patient's past medical history included urinary tract infection. Concurrent medical conditions included bipolar, hypothyroidism, knee arthritis and lupus. Concurrent medications included tylenol with codeine no. 3 (tylenol with codeine #3), "azo", hydrochlorothiazide, clonazepam, semisodium valproate (depakote, thyroxine sodium (levothyroxine), injectable arthritis medication and unknown injection for lupus. On an unknown date(s), the patient started the formulations of double salt denture cleanser. At an unknown time after starting the formulations for double salt denture cleanser, the patient experienced urinary tract infection and burning on urination. The patient was hospitalized. The patient was treated with ciprofloxacin hydrochloride (cipro). Treatment with double salt denture cleanser was continued. At the time of reporting, the events were unresolved. Sae reported (b)(6) via phone: consumer reported that she has frequent visits to the hospital for urinary tract infections. She stated that approximately two years ago after she had her teeth extracted she was admitted into the hospital for a urinary tract infection for three days. She could not provide the specific dates or details about her hospital admission. She reported that she did not tell the doctor's that she was using polident while she was in the hospital. She also stated that her doctor now is not aware that she's using polident. She stated that the cause of her frequent urinary tract infections is unknown. She stated that she has seen a kidney specialist and was told that her kidneys look good. Consumer reported that when she has a urinary tract infection she wakes up at night and has really bad burning while urinating. She stated that she was started on cipro 500 mg twice a day yesterday, (b)(6) 2013, to treat her current urinary infection. She reported that she has appointment with her doctor on the (b)(6) for a follow up but did not state the month of her follow up appointment.
Patient Sequence No: 1, Text Type: D, B5
[17366907]
Polident tablets are manufactured in (b)(4). The lot number for this product is available; however, it is unknown whether the product will be returned for quality assurance testing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020379-2013-00007 |
| MDR Report Key | 3259938 |
| Report Source | 04 |
| Date Received | 2013-07-30 |
| Date of Report | 2013-07-29 |
| Date Mfgr Received | 2013-07-25 |
| Date Added to Maude | 2013-08-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | BLOCK DRUG CO., INC., MEMPHIS FACILITY |
| Manufacturer Street | 2149 HARBOR AVE. |
| Manufacturer City | MEMPHIS TN 38113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT DENTURE CLEANSER TABLETS |
| Generic Name | DOUBLE SALT DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2013-07-30 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | MB1913 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-07-30 |