MAUDE Adverse Event Report: DERMA SCIENCES, INC. COMVITA WOUND GEL 25 GRAM TUBE STERILE 1'S; PRIVATE LABEL - COMVITA

Catalog Number COM389

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that a patient experienced an adverse reaction after a medihoney wound gel was applied.After application of the medihoney on the patient's face on an area approximately 1.5cm x 1.5cm, it was noted that the patient's eyes and cheeks swelled, became lethargic and had projectile vomiting.The mother thought that the patient had a "tummy bug" so she reapplied the gel but the same reaction happened again.On the next day, the patient did not have a high temperature and was fine.Child had honey before with no issues but this was the first time using wound gel.No additional information was provided after several attempts.

Manufacturer Narrative

The device in question was not returned for evaluation.Device history record (dhr) can not be reviewed as no samples, lot number or product code was provided by end user.Also, root cause is unknown as no additional information was received.

Manufacturer Narrative

Additional information was received on 19aug2018.Item number (b)(4) which is the 25g tube of wound gel.No lot number provided by the customer.No additional information was provided after several attempts.The customer had been advised to stop taking the product.Dhr can not be reviewed, product code was provided by the customer, however, no lot number was provided or available.Failure mode is still not confirmed.Unknown root cause as no additional information was received from end user.

• Brand Name: COMVITA WOUND GEL 25 GRAM TUBE STERILE 1'S
• Type of Device: PRIVATE LABEL - COMVITA
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• MDR Report Key: 7600759
• MDR Text Key: 111047408
• Report Number: 9680091-2018-00019
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K101793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: COM389
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 MO