MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-07-02 for CLEANIC 3184 manufactured by Kerrhawe.
[18062213]
A doctor alleged that a patient had experienced an allergic reaction with symptoms of throat irritation, rashes on hands, feet, and gluteal after receiving treatment with cleanic.
Patient Sequence No: 1, Text Type: D, B5
[18402805]
To date, the patient is doing fine. The doctor prescribed cortisone for the patient, without further incident. The product involved in the alleged incident was not returned; therefore, no evaluations can be conduct. No further evaluations needed since an allergic reaction could not be replicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020994-2013-00002 |
| MDR Report Key | 3201887 |
| Report Source | * |
| Date Received | 2013-07-02 |
| Date of Report | 2013-06-25 |
| Date of Event | 2013-06-19 |
| Date Added to Maude | 2013-07-02 |
| 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 | CLEANIC |
| Generic Name | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
| Product Code | EJR |
| Date Received | 2013-07-02 |
| Catalog Number | 3184 |
| Lot Number | 4625004 |
| Device Expiration Date | 2014-02-28 |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2013-07-02 |