MAUDE Adverse Event Report: INTEGRA LIFE SCIENCES CORPORATION MEDIHONEY GEL AND DRESSING; DRESSING, WOUND, DRUG

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/01/2018

Event Type  Injury  

Event Description

Patient was prescribed medihoney gel (integra life sciences) to use as a wound protectant.He then developed a severe allergic contact dermatitis due to the medihoney gel.He had a positive open application test with the product.No reaction to propolis.He is allergic to propylene glycol, fragrances, and tea tree oil, none of which are listed as ingredients on medihoney gel (label says 80% manuka honey, 20% "other") fda safety report id # (b)(4).

• Brand Name: MEDIHONEY GEL AND DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): INTEGRA LIFE SCIENCES CORPORATION
• MDR Report Key: 10307571
• MDR Text Key: 200215169
• Report Number: MW5095650
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• 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: 07/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR