MAUDE Adverse Event Report: GRIF GRIPS ADHESIVE; TAPE AND BANDAGE ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypoglycemia (1912); Rash (2033); Skin Inflammation (2443)

Event Date 04/24/2019

Event Type  Injury  

Event Description

A (b)(6) y/o (b)(6) american female with history of dm2 who is participating in a diabetes medication clinical trial (grade) who developed an apparent severe local contact dermatitis at the site of placement of her libre continuous glucometer (cgm).Simultaneously, she had multiple recordings of hypoglycemia which she reported were asymptomatic.Per the study protocol, the cgm readings were 'blind' to both the pt and were reported to study staff at a later time.The cgm was placed on (b)(6) 2019 on the right upper outer arm where there was notably an adjacent skin tatoo.The rn noted that the tatoo did have several areas of raised but non-inflamed skin mostly in the areas with red link.The cgm was placed in an area without tatoo ink.On (b)(6) 2019 the pt was seen at her scheduled f/u visit and reported that she had removed the adhesive and filament one day prior due to a pruritic rash.She had subsequently self treated with neosporin ointment.On exam there was a raised, erythematous papular rash with weeping and reported severe pruritis on the exact shape and size of the square (approx 4 x 4cm) adhesive 'griff grips' and a raised red ring immediately surrounding the filament entry to the subcutaneous space.Two days later on re-exam, the rash persisted despite.Pmhs: type 2 diabetes mellitus, migraine, anxiety - depression, seasonal allergy, allergies: penicillins (skin rash), clindamycin (skin rash), cortisone and hydrocortisone (skin rash), omeprazole (skin rash), hydrocodone - acetaminophen (not specified), hmg-coa reductase inhibitors (suicidal ideation).No alcohol or tobacco use.

• Brand Name: GRIF GRIPS ADHESIVE
• Type of Device: TAPE AND BANDAGE ADHESIVE
• MDR Report Key: 8851305
• MDR Text Key: 152968848
• Report Number: MW5088628
• Device Sequence Number: 2
• Product Code: KGX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN ; ETONOGESTREL IMPLANT; FLUTICASONE NASAL ; GABAPENTIN ; GLIMEPIRIDE; METFORMIN ; MONTELUKAST ; RIZATRIPTAN SL PRN ; SERTRALINE; SKIN TAC ADHESIVE ; SUMATRIPTAN SQ PRN ; TOPIRAMATE
• Patient Age: 44 YR
• Patient Weight: 78