MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-26 for MPHI F9000235 manufactured by Asa Srl.
[90325774]
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
[90325775]
The patient reported a red burn, itchy lesion on right posterior shoulder a few hours after the first therapy session.
Patient Sequence No: 1, Text Type: D, B5
[93332606]
After analyzing the documentation, we believe that the reported event cannot be considered a serious injury. The patient has a trivial (superficial and temporary) skin damage. Therefore, the following definition is not applicable to this case: serious injury means an injury or illness that: is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage. The dhr doesn't show any irregularities during the production phase and shows correct and regular values in the laser emission, functional and electrical safety tests. No service activities have been performed on the device after the sale of the device. The laser emission measurements taken after the event don't show any anomalies in the system. The scheduled post-market monitoring of the treatments performed with same or similar devices doesn't show any undesirable side effects similar to the ones described in this case, neither with the same treating parameters, nor with different treating parameters. According to our analysis, there are no actions to be taken on the device or on the market. However, we will maintain a high level of market surveillance to monitor similar events. If the fda doesn't have any further notes regarding this case, we consider the case closed.
Patient Sequence No: 1, Text Type: N, H10
[93332607]
The patient reported a red burn, itchy lesion on right posterior shoulder a few hours after the first therapy session.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004724437-2017-00001 |
| MDR Report Key | 6979702 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-26 |
| Date of Report | 2017-11-24 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2017-07-06 |
| Date Added to Maude | 2017-10-26 |
| 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 | 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 | MPHI |
| Generic Name | LASER THERAPY |
| Product Code | ILY |
| Date Received | 2017-10-26 |
| Model Number | F9000235 |
| Catalog Number | MPHI |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-26 |