MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-11 for APEX POINTER+ 51300027 manufactured by Micro-mega Societe Anonyme.
[189076843]
This declaration is based on photo sent to us. This photo is showing traces on the cheek of the patient. The dentist thinks it could be linked to the use of the apex locator. Micro-mega is not sure that the traces is a burn or an irritation or an allergy. Also, we are not sure that this injury is due to the device apex pointer +. The dentist made a local treatment to treat traces: physiological serum and vaseline; through our information's, no other actions have been done by health professional. The device has been tested in our facilities: no problem has been detected. Note: the device is powered by battery (max 6 v dc) - date (b)(6) 2017. It is the first case that we became aware. This device is not marketing any more. So we did not engage any actions.
Patient Sequence No: 1, Text Type: N, H10
[189076844]
24 hours after dental treatment using an apex locator, there appeared traces ressembling to an allergy or irritiaion on the external side of the patient cheek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030962-2017-00001 |
| MDR Report Key | 9579315 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-11 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-11 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2020-01-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHILIPPE CONCHE |
| Manufacturer Street | 5-12 RUE DU TUNNEL |
| Manufacturer City | BESANCON, 25006 |
| Manufacturer Country | FR |
| Manufacturer Postal | 25006 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX POINTER+ |
| Generic Name | APEX POINTER+ |
| Product Code | LQY |
| Date Received | 2020-01-11 |
| Returned To Mfg | 2017-10-30 |
| Catalog Number | 51300027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO-MEGA SOCIETE ANONYME |
| Manufacturer Address | 5-12 RUE DU TUNNEL BESANCON, 25006 FR 25006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-11 |