MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for ECLIPSE ELITE MICROPEN MP-1001-11 manufactured by Eclipse Medcorp.
[140606599]
A (b)(6) yo male patient with dx of significant perioral rhytids. Prp blood draw mixed with ha and applied to tx area. Microneedled tx area with eclipse elite micropen several passes. Upon cessation of tx, removed eclipse elite needle cartridge and observed blood (still wet) deep inside motor chamber. Unable to remove or clean. Contacted eclipse via phone and was told that eclipse aesthetics does not sell the elite in the usa. I informed customer service agent that device was purchased in (b)(6) 2018 from (b)(6) - sales rep. Eclipse aesthetics informed me that i needed to contact (b)(6) and that eclipse aesthetics has nothing to do with sales of the elite in the usa. Customer service rep refused to take report of malfunction. Blood residue photographed. I own two other eclipse elite micropens purchased after (b)(6) 2018. Sn's (b)(4). Upon inspection on (b)(6) 2019, blood residue was observed and photographed. I am willing to send the devices to fda for inspection. Cartridges used were from lot #ecl020030-180719 with expiration of 19-jul-2021. Cartridges disposed of in sharps container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085389 |
| MDR Report Key | 8469845 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-12 |
| Date Added to Maude | 2019-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ECLIPSE ELITE MICROPEN |
| Generic Name | BRUSH, DERMABRASION POWERED |
| Product Code | GFE |
| Date Received | 2019-03-29 |
| Model Number | MP-1001-11 |
| Lot Number | ECL020030-180719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECLIPSE MEDCORP |
| Brand Name | ECLIPSE ELITE MICROPEN |
| Generic Name | BRUSH, DERMABRASION POWERED |
| Product Code | GFE |
| Date Received | 2019-03-29 |
| Model Number | MP-1001-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ECLIPSE MEDCORP |
| Brand Name | ECLIPSE ELITE MICROPEN |
| Generic Name | BRUSH, DERMABRASION POWERED |
| Product Code | GFE |
| Date Received | 2019-03-29 |
| Model Number | MP-1001-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ECLIPSE MEDCORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |