MAUDE Adverse Event Report: DEXCOM, INC. OVERPATCH; TAPE AND BANDAGE, ADHESIVE

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  malfunction  

Event Description

The overpatch supplied by dexcom is a piece of junk, it is impossible for one person to put it on.It is so flimsy it folds up on itself, you cannot peel it apart because it stretches out of shape.They do not even have a way to get extra overpatch.Every time i complain about it to dexcom, the answer is we supply an overpatch with each sensor.

• Brand Name: OVERPATCH
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 16763540
• MDR Text Key: 313575915
• Report Number: MW5116754
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2023
• Patient Sequence Number: 1
• Treatment: DEXCOM G7
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White