MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for CARE ONE DENTURE CLEANSER - 3 MINUTE manufactured by Tower Laboratories Ltd..
[138207034]
Care one denture cleanser does contains persulfates. There is a warning on the label identifying persulfates are in the product as well as them being a known allergen. No product was returned for evaluation. The evaluation summary attached is an analysis of retain samples from the specific lot number identified by the patient. All test results were confirmed to be within specification.
Patient Sequence No: 1, Text Type: N, H10
[138207035]
Reporter stated patient had a severe life threatening reaction to persulfates. Patient's hands got itchy, she had a seizure, she went into respiratory arrest, had low blood pressure, and low temp. Patient was hospitalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001219540-2019-00001 |
| MDR Report Key | 8401557 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2018-08-08 |
| Date Added to Maude | 2019-03-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CRYSTAL FISHER |
| Manufacturer Street | 8 INDUSTRIAL PARK ROAD |
| Manufacturer City | CENTERBROOK CT 06409 |
| Manufacturer Country | US |
| Manufacturer Postal | 06409 |
| Manufacturer Phone | 8607672127 |
| Manufacturer G1 | TOWER LABORATORIES LTD. |
| Manufacturer Street | 8 INDUSTRIAL PARK ROAD |
| Manufacturer City | CENTERBROOK CT 06409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARE ONE DENTURE CLEANSER - 3 MINUTE |
| Generic Name | BILAYER 3-MINUTE DENTURE CLEANSER TABLETS |
| Product Code | EFT |
| Date Received | 2019-03-07 |
| Lot Number | 8220010 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOWER LABORATORIES LTD. |
| Manufacturer Address | 8 INDUSTRIAL PARK ROAD CENTERBROOK CT 06409 US 06409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-07 |