MAUDE Adverse Event Report: ASA SRL M8; LASER THERAPY

Model Number F900047

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Patient underwent a total replacement of the dexter hip joint on (b)(6) 2021.The doctor prescribed 3 cold laser treatments to patient on may 5, 2021, to being after (b)(6) 2021.Laser treatment performed on patient on (b)(6) 2021.Received letter dated june 23, 2021, on june 28, 2021 from patient claiming "negative reaction" to his right leg caused by the laser treatment from (b)(6) 2021.Patient has not returned to the clinical facility were the treatment was performed since (b)(6) 2021.The medical experts stated that the symptoms described were a typical post-operative response call ecchymosis (where dark spots form on the skin caused by the blood that has seeped from ruptured or severed, but healing vessels).Post-operative ecchymosis typically presents near the incision site and radiates from there, often towards the patient's legs as gravity works.It can present immediately or sometime later when the patient becomes more active and the blood moves to the surface.That is exactly what the patient describes occurred.We ruled out any topical burning by the laser, as the procedure was only performed on the patient's thigh and the discoloration occurred thereafter.The dhr check of the device and the history of its service interventions do not show any anomalies that could be related to anomalous laser emissions.The technical check carried out on july 06, 2021, confirms the regular functioning of the device, therefore a malfunction of the device itself is excluded.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, and now he doesn't have reported any consequences.Therefore, the following definition is not applicable to this case: (w) serious injury means an injury or illness that: (1) is life-threatening, (2) results in permanent impairment of a body function or permanent damage to a body structure, or (3) 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.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

Received letter dated june 23, 2021 from patient claiming "negative reaction" to his right leg caused by the laser treatment from (b)(6) 2021.The patient wrote that they have a total right hip replacement on (b)(6), had a laser treatment on the right hip on (b)(6) and the thigh started aching and burning, on (b)(6) the leg was swelling and beginning to discolor.The pain, heat in the thigh, swelling and discoloration lasted for 10 days.

• Brand Name: M8
• Type of Device: LASER THERAPY
• Manufacturer (Section D): ASA SRL; via galileo galilei 23; arcugnano, 36057 ; IT 36057
• Manufacturer (Section G): ASA SRL; via galileo galilei 23; arcugnano, italy 36057 ; IT 36057
• Manufacturer Contact: lucio zaghetto ; via galileo galilei 23; arcugnano, italy 36057 ; IT 36057
• MDR Report Key: 12238195
• MDR Text Key: 263820869
• Report Number: 3004724437-2021-00002
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F900047
• Device Catalogue Number: M8
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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
• Treatment: ALLOPURINO L 300 MG TABLET; APIXABAN 5 MG (74 TABS) TABLETS IN A DOSE PACK; GLIPIZIDE 10 MG TABLET; LOSARTAN 50 MG TABLET; METOPROLOL SUCC 25 MG-HYDROCHLOROTHIAZIDE 12.5 MG; OMEPRAZOLE 10 MG CAPSULE,DELAYED RELEASE; PREGABALIN 100 MG CAPSULE
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 89