MAUDE Adverse Event Report: ASA SRL MIX5; LASER THERAPY

Model Number F9000198

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

Adequate information to complete the investigation on the case is not yet available.The investigation activities continue and will follow follow-up.

Event Description

The patient reported back pain and skin rash on the back of the neck after the 3th session of the therapy.

Manufacturer Narrative

After analyzing the documentation, we believe that the reported event cannot be considered a serious injury.The patient has been experiencing a temporary skin rash months before the complaint submission and now he doesn't have reported any consequences.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.The service activities performed on the device after its sale didn't show problems related to the emission values of the device.The laser emission measurements taken after the event don't show any over-emission 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.Moreover, the scientific literature doesn't show any contraindications in using diode laser emissions with titanium plaques.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.

Event Description

The patient reported back pain and skin rash on the back of the neck after the 3th session of the therapy.

• Brand Name: MIX5
• Type of Device: LASER THERAPY
• Manufacturer (Section D): ASA SRL; via alessandro volta 9; arcugnano, 36057 ; IT 36057
• Manufacturer (Section G): ASA SRL; via alessandro volta 9; arcugnano, 36057 ; IT 36057
• Manufacturer Contact: lucio zaghetto ; via alessandro volta 9; arcugnano, 36057 ; IT 36057
• MDR Report Key: 6998573
• MDR Text Key: 90933028
• Report Number: 3004724437-2017-00004
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: F9000198
• Device Catalogue Number: MIX5
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR