MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-30 for FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN manufactured by Braun Gmbh Werk Marktheidenfeld.
[16226567]
Copper deficiencies [copper deficiency]. Case description: a husband reported via social media that his wife of unspecified age used fixodent denture adhesive, form/version unknown on unspecified date. The husband asserted that the fixodent put his wife in the hospital and almost the grave. The husband posted go online and pull up copper deficiencies, it takes years for this to happen. The case outcome was unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[16392665]
Lot number and product were not provided by reporter, therefore, cannot proceed with batch retain testing or product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530449-2015-00009 |
| MDR Report Key | 4952939 |
| Report Source | 04 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-06-30 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-07-30 |
| 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 Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Street | 6200 BRYAN PARK ROAD |
| Manufacturer City | BROWN SUMMIT NC 27214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-07-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAUN GMBH WERK MARKTHEIDENFELD |
| Manufacturer Address | 40 BAUMHOFSTRASSE MARKTHEIDENFELD, D-97828 GM D-97828 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-07-30 |