MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-30 for CVS EXTRA STRENGTH DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals.
[6191177]
Customer complained that she used denture adhesive twice, the first time it was extremely difficult to pull out her dentures. She used it again and she pulled her denture out, it pulled a layer of skin off. It was bleeding from the roof of her mouth near the gums.
Patient Sequence No: 1, Text Type: D, B5
[14216766]
Complaint investigation still in process. Suspect sample has not yet been returned to sheffield pharmaceuticals. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1210513-2015-00147 |
| MDR Report Key | 4961113 |
| Report Source | 07 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-07-08 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-08-04 |
| 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 | 170 BROAD ST. |
| Manufacturer City | NEW LONDON CT 06320 |
| Manufacturer Country | US |
| Manufacturer Postal | 06320 |
| Manufacturer Phone | 8604424451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVS EXTRA STRENGTH DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-07-30 |
| Lot Number | 50021 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHEFFIELD PHARMACEUTICALS |
| Manufacturer Address | NEW LONDON CT 06320 US 06320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-30 |