MAUDE Adverse Event Report: SANOFI US SERVICES INC. MY DOSE COACH SOFTWARE

Lot Number UNKNOWN

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

Patient Problem Ulcer (2274)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Diabetic foot syndrome (diabetic foot; ulcus cruris). Case narrative: initial information received on (b)(6)2022 regarding an unsolicited valid serious case received from a physician from (b)(6). This case involves adult and unknown gender patient who had diabetic foot syndrome with the use of medical device my dose coach. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient started using my dose coach (with an unknown strength, dose, frequency, formulation, route, batch number, expiry date, batch number and indication). On (b)(6)2021 the patient developed diabetic foot syndrome (diabetic foot) (unknown latency) after starting use of my dose coach. This event was assessed as medically significant and required surgical intervention. On (b)(6) 2021 the patient after unknown latency patient had wound on the right sole was ascertained by the podiatrist for which partial resection of the fourth and (digit) right foot after ulcus at the hospital (skin ulcer). After that regular cleaning of foot through outpatient treatment of foot was done from (b)(6) 2021 and three times a week care service was provided. The investigator's assessment was that the event was independent of the use of my dose coach and was not likely to be related to the participation in the study. Action taken: unknown. Corrective treatment: partial resection and outpatient treatment at time of reporting, the outcome was recovered on (b)(6) 2021. Based on information previously received the patient imdrf annex e has been updated from (b)(4).

• Brand Name: MY DOSE COACH
• Type of Device: SOFTWARE
• Manufacturer (Section D): SANOFI US SERVICES INC.; 270 albany street; cambridge 02139
• Manufacturer (Section G): SANOFI US SERVICES INC.; 270 albany street; cambridge 02139
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 13364483
• MDR Text Key: 289250780
• Report Number: 3010770778-2022-00002
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/27/2022 Patient Sequence Number: 1