MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-13 for C+B PELO SYSTEM 1042 manufactured by Gme German Medical Engineering.
[110961147]
The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[110961148]
The patient had multiple sites treated; upper lip, chin, axilla and the front and back of the lower legs. The lower legs were treated last. The technician applied aloe to the patients lower legs afterwards due to discomfort. The patient states that later in the evening, or it could have been first thing in the morning, raised red welts in a polka dot formation appeared. The doctor put the patient on benadryl and 1% hydrocortisone cream. The patient is improving and permanent damage or scarring is not likely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00057 |
| MDR Report Key | 7598141 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-13 |
| Date of Report | 2018-05-16 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-06-13 |
| 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 Contact | MRS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ERLANGEN MO |
| Manufacturer Country | GM |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | GME GERMAN MEDICAL ENGINEERING |
| Manufacturer Street | 11720 N CREEK PARKWAY N STE 100 |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C+B PELO SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2018-06-13 |
| Model Number | 1042 |
| ID Number | NI |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GME GERMAN MEDICAL ENGINEERING |
| Manufacturer Address | 11720 N CREEK PARKWAY N STE100 ERLANGEN WA GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-13 |