MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-22 for ICON 105-2500-000 R105-2500-000 manufactured by Cynosure Inc..
[136906322]
In this incident, patient experienced a burn and erythema on the bikini area following a hair removal procedure with the icon's max r ipl handpiece. This resulted in the patient having medical intervention at a burn clinic and receiving medication cream for post treatment care. It was determined that the treatment did not follow the clinical reference guidelines, therefore user error was involved. In addition, the operator performed the procedure too close to an existing tattoo. The clinical reference guide was not followed as it cautions: "caution: avoid treating within one inch or directly over any tattoo or permanent cosmetic makeup/tattoos. Doing so can result in skin damage or ink color changes". Patient is now doing well from the incident. Burns/erythema are expected side effects from such hair removal treatments, however this event is reportable because the patient had medical intervention.
Patient Sequence No: 1, Text Type: N, H10
[136906323]
Patient had medical intervention following a hair removal procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2019-00004 |
| MDR Report Key | 8362901 |
| Report Source | CONSUMER |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2019-02-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 5 CARLISLE ROAD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON |
| Generic Name | ICON |
| Product Code | PKT |
| Date Received | 2019-02-22 |
| Model Number | 105-2500-000 |
| Catalog Number | R105-2500-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE INC. |
| Manufacturer Address | 5 CARLISLE ROAD WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-22 |