MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2003-12-05 for DENTURE CLEANSER POWDER * manufactured by Glaxo Smithkline Consumer Healthcare Medical Affairs, Us Product Safety.
[20990667]
The 2002 annual report of the american association of poison control centers (aapcc) toxic exposure surveillance system described the occurrence of profound hypotension in a pt who used denture cleanser powder, manufacturer unk. This was the only case report involving a denture cleanser reported by the aapcc. It was reported that the pt unintentionally applied the denture powder to their dentures while they were still in their mouth. During evaluation in an emergency department, they were found to have severe burns to their lips, mouth and oropharynx with swelling and drooling. They required endotracheal intubation for respiratory distress secondary to increased secretions and irritation. They developed profound hypotension and died. Manufacturer's comment: glaxosmithkline markets a denture cleanser powder under the brand name polident denture power. Polident denture cleanser powder is manufactured in memphis, tennessee. The lot number for this product is not available; therefore, quality testing will not be performed. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2003-00001 |
| MDR Report Key | 500433 |
| Report Source | 03,05 |
| Date Received | 2003-12-05 |
| Date of Report | 2003-12-04 |
| Date Mfgr Received | 2003-11-04 |
| Date Added to Maude | 2003-12-15 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON ROAD |
| Manufacturer City | PARSIPPANY NJ 070543884 |
| Manufacturer Country | US |
| Manufacturer Postal | 070543884 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | MEMPHIS FACILITY |
| Manufacturer Street | 2149 HARBOR AVENUE |
| Manufacturer City | MEMPHIS TN 36113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTURE CLEANSER POWDER |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2003-12-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 489200 |
| Manufacturer | GLAXO SMITHKLINE CONSUMER HEALTHCARE MEDICAL AFFAIRS, US PRODUCT SAFETY |
| Manufacturer Address | 1500 LITTLETON ROAD PARSIPPANY NJ 070543884 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening; 3. Required No Informationntervention | 2003-12-05 |