MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-01 for POLIDENT DENTU CREME manufactured by Gsk East Durham.
[140453742]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140453743]
I might have swallowed some [accidental device ingestion], cause breathing issues and all this is that true [difficulty breathing], i brushed my teeth with this [device use issue], this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received denture cleanser (polident dentu creme) toothpaste (batch number ilit258h, expiry date 31st march 2020) for dental cleaning. On an unknown date, the patient started polident dentu creme. On an unknown date, an unknown time after starting polident dentu creme, the patient experienced accidental device ingestion (serious criteria gsk medically significant), difficulty breathing and device use issue. The action taken with polident dentu creme was unknown. On an unknown date, the outcome of the accidental device ingestion, difficulty breathing and device use issue were unknown. It was unknown if the reporter considered the accidental device ingestion and device use issue to be related to polident dentu creme. The reporter considered the difficulty breathing to be related to polident dentu creme. Additional details: the adverse event information was received via phone call on (b)(6) 2019. The consumer reported that, "i am calling in about polident creme, i brushed my teeth with this, i did not mean too. I looked it up online, it could cause breathing issues and all this, is that true? I might have swallowed some. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314819-2019-00002 |
| MDR Report Key | 8469168 |
| Report Source | CONSUMER |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-18 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-04-01 |
| 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 DENTU CREME |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-04-01 |
| Lot Number | ILIT258H |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GSK EAST DURHAM |
| Manufacturer Address | EAST DURHAM NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-01 |