MAUDE Adverse Event Report: DERMA SCIENCES, INC. MEDIHONEY UNKNOWN; N/A

Catalog Number XXX-MEDIHONEY

Device Problem Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Event Description

The customer reported a medihoney (unknown id) she bought at amazon with and expiration date, january 3, 2027.When she apply it on her finger the texture has little pieces/grains and it is not smooth.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10.The medihoney was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: MEDIHONEY UNKNOWN
• Type of Device: N/A
• 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 ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17924104
• MDR Text Key: 325823541
• Report Number: 9680091-2023-00006
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: XXX-MEDIHONEY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1