MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-03-26 for DENTO-SURG 90 F.F.P.F EMC EMCD220EU manufactured by Ellman International.
[4432081]
A blepharoplasty was being performed using the f. F. P. F. Emc generator. During the procedure, the eyelid was burned. The burn area was excised.
Patient Sequence No: 1, Text Type: D, B5
[11747800]
The device is being returned from (b)(6) and will be inspected once it is received. Additional information is also be requested from the distributor. Additional information report(s) will be filed as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2428235-2014-00001 |
| MDR Report Key | 3772332 |
| Report Source | 01,08 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-24 |
| Date of Event | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2014-05-19 |
| 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 | 400 KARIN LANE |
| Manufacturer City | HICKSVILLE NY 11801 |
| Manufacturer Country | US |
| Manufacturer Postal | 11801 |
| Manufacturer Phone | 5136588960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTO-SURG 90 F.F.P.F EMC |
| Generic Name | RADIOFREQUENCY GENERATOR |
| Product Code | EKZ |
| Date Received | 2014-03-26 |
| Model Number | EMCD220EU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELLMAN INTERNATIONAL |
| Manufacturer Address | HICKSVILLE NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-26 |