MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-03-20 for POLIDENT DENTURE ADHESIVE CREAM manufactured by Gsk Dungarvan Stafford Miller.
[5654012]
Accidental ingestion of product [accidental ingestion of product]. Case description: this case was reported by a consumer and described the occurrence of accidental ingestion of product in an (b)(6)-year-old-male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for an unk indication. In 2015, the patient started polident denture adhesive cream, the patient experienced accidental ingestion of product. On an unk date, the outcome of the accidental ingestion of product was unk. It was unk if the reporter considered the accidental ingestion of product to be related to polident denture adhesive cream.
Patient Sequence No: 1, Text Type: D, B5
[13106236]
Additional info: reporter reported that his father's teeth had been removed recently. He had been using the denture for few days. Dentist recommended him to use this product. It was his first time to use it. He had used 3 dips of products on the lower and upper denture respectively once per day. Reporter enquired that if it was fine to swallow the product when drinking water. Reporter reported that the product may have been swallowed with saliva accidentally when using the dentures. He also reported that the product may have been swallowed accidentally when removing the dentures. His father did not feel discomfort after swallowing the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681138-2015-00011 |
| MDR Report Key | 4623001 |
| Report Source | 01,04 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-03-05 |
| Date Mfgr Received | 2015-03-05 |
| Date Added to Maude | 2015-03-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT DENTURE ADHESIVE CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-03-20 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GSK DUNGARVAN STAFFORD MILLER |
| Manufacturer Address | DUNGARVAN, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |