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U.S. Department of Health and Human Services

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

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SANOFI US SERVICES INC. MY DOSE COACH SOFTWARE Back to Search Results
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).
 
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Brand NameMY DOSE COACH
Type of DeviceSOFTWARE
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 Key13364483
MDR Text Key289250780
Report Number3010770778-2022-00002
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
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 Received01/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
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
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