MAUDE Adverse Event Report: DERMA SCIENCES, INC. MEDIHONEY TUBE - 1.5 FL OZ (44 ML) - STERILE; MEDIHONEY OTHER

Catalog Number 31515

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported last week by a customer that a patient experienced skin irritation after a 1.5 fl oz medihoney tube was applied.After application of the medihoney on the patient's ulcer at the back, it was noted that it was runny or totally different as it goes down further on the patient's back.Subsequently, the patient's skin became sore and irritated.A wound care specialist was consulted and an antibiotic cream was applied on the wound.The usage of the medihoney was discontinued.No further patient complications were reported.

Manufacturer Narrative

The device involved in the reported incident was not returned.Dhr can not be reviewed as no lot number was received.The root cause could not be determined.

• Brand Name: MEDIHONEY TUBE - 1.5 FL OZ (44 ML) - STERILE
• Type of Device: MEDIHONEY OTHER
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer (Section G): DERMA SCIENCES, INC.; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7534451
• MDR Text Key: 108929177
• Report Number: 9680091-2018-00018
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K080315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 31515
• Device Lot Number: 17202021-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other