MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-09-02 for SUPERPOLISH 361 manufactured by Kerrhawe.
[19411019]
The patient was referred to a dermatologist and sought further treatment on (b)(6) 2013. The dermatologist prescribed an oral corticoid for treatment, which alleviated the symptoms. The patient is expected to return for an epicutaneous test; however, no appointment has been set at this time. To date, the patient has fully recovered and is doing fine. The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted. No further evaluation is required since an allergic reaction cannot be replicated.
Patient Sequence No: 1, Text Type: N, H10
[19482610]
A doctor alleged that a patient had experienced an immediate reaction to the superpolish paste with symptoms of edema, larynx swelling, and oral dx "squamationen" on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020994-2013-00003 |
| MDR Report Key | 3321032 |
| Report Source | 00,05 |
| Date Received | 2013-09-02 |
| Date of Report | 2013-08-23 |
| Date of Event | 2013-07-17 |
| Date Mfgr Received | 2013-08-23 |
| Date Added to Maude | 2013-09-03 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | KERRHAWE |
| Manufacturer Street | VIA STRECCE 4 PO BOX 268 |
| Manufacturer City | BIOGGIO, 6934 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6934 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERPOLISH |
| Generic Name | ORAL CAVITY ABRASIVE POLISHING AGENT |
| Product Code | EJR |
| Date Received | 2013-09-02 |
| Catalog Number | 361 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERRHAWE |
| Manufacturer Address | VIA STRECCE 4 PO BOX 268 BIOGGIO, 6934 SZ 6934 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-09-02 |