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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASA SRL MPHI LASER THERAPY

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ASA SRL MPHI LASER THERAPY Back to Search Results
Model Number F9000235
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Burn, Thermal (2530)
Event Date 09/15/2017
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 a red burn, itchy lesion on right posterior shoulder a few hours after the first therapy session.
 
Manufacturer Narrative
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.
 
Event Description
The patient reported a red burn, itchy lesion on right posterior shoulder a few hours after the first therapy session.
 
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Brand NameMPHI
Type of DeviceLASER 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 Key6979702
MDR Text Key90325774
Report Number3004724437-2017-00001
Device Sequence Number1
Product Code ILY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF9000235
Device Catalogue NumberMPHI
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/26/2017 Patient Sequence Number: 1
Treatment
IBUPROFEN
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