MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-03 for MIX5 F9000198 manufactured by Asa Srl.
[90932921]
Adequate information to complete the investigation on the case is not yet available. The investigation activities continue and will follow follow-up.
Patient Sequence No: 1, Text Type: N, H10
[90932922]
The patient reported back pain and skin rash on the back of the neck after the 3th session of the therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004724437-2017-00003 |
| MDR Report Key | 6998575 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-03 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-09-15 |
| Device Manufacturer Date | 2012-01-13 |
| Date Added to Maude | 2017-11-03 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LUCIO ZAGHETTO |
| Manufacturer Street | VIA ALESSANDRO VOLTA 9 |
| Manufacturer City | ARCUGNANO, 36057 |
| Manufacturer Country | IT |
| Manufacturer Postal | 36057 |
| Manufacturer G1 | ASA SRL |
| Manufacturer Street | VIA ALESSANDRO VOLTA 9 |
| Manufacturer City | ARCUGNANO, 36057 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 36057 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIX5 |
| Generic Name | LASER THERAPY |
| Product Code | ILY |
| Date Received | 2017-11-03 |
| Model Number | F9000198 |
| Catalog Number | MIX5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASA SRL |
| Manufacturer Address | VIA ALESSANDRO VOLTA 9 ARCUGNANO, 36057 IT 36057 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-03 |