MAUDE Adverse Event Report: DERMA SCIENCES, INC. MEDIHONEY GEL IN TUBE, 1.5 FL OZ FLIPCAP - STERILE

Catalog Number	31815
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fever (1858); Inflammation (1932); Pain (1994)
Date of Event	07/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer/patient reported experiencing low grade fever, and not feeling good in general after medihoney gel use (id (b)(6)).It was stated that the customer was admitted to the hospital.Additional information received: - reason for medihoney use - "prescribed for an infected wound on the chest wall (metastatic breast cancer site)." - start date of medihoney use - "approximately (b)(6) 2025, after product purchase." - date fever started - "around (b)(6) 2025 (low-grade fevers at home), progressing by (b)(6) 2025 to higher fever." - did you take your temperature? "yes.At home, my temperature rose as high as 102°f (my baseline is ~97°f).In the hospital, my temperature was also documented at 102°f." - wound site symptoms - "increasing pain, drainage, redness, and swelling prior to hospitalization." - do you have a prescription for medihoney? - "yes, prescribed".- where was the medihoney acquired? - "sam¿s club pharmacy, butler, pa.Purchased (b)(6) 2025.I have retained the receipt." - can you please provide a photo of the packaging and/or the tube (both sides)? - "product packaging and tube (lot 2450, catalog #31815) ".- can you please confirm if you were admitted due to fever? - "yes, admitted (b)(6) 2025, for fever and infected wound." - cultures and lab tests performed - "wound cultures confirmed severe polymicrobial bacterial infection." - "first hospitalization: ((b)(6) 2025): heavy pseudomonas aeruginosa (two strains), enterococcus faecalis, methicillin-sensitive staphylococcus aureus (mssa), actinotignum schaalii, bacteroides fragilis, slackia exigua, and 75,000¿99,000 cfu/ml klebsiella variicola." - "second hospitalization ((b)(6) 2025): many staphylococci aureus, enterococcus faecalis, pseudomonas aeruginosa, enterobacter cloacae complex.Bloodwork: white blood cell counts were elevated.Liver enzymes (ast, alt) were also elevated at that time." - treatment given - "first hospitalization: ((b)(6) 2025): iv vancomycin, transitioned to iv zosyn (piperacillin¿tazobactam)." - "second hospitalization: ((b)(6) 2025): discharged on oral augmentin + ciprofloxacin." - current condition - "still recovering." - "lost ~10 lbs and significant strength during hospitalizations." - "experiencing ongoing yeast infections following antibiotic treatment." - "emotional stress and disruption from two hospital stays." - "immunotherapy treatment (ipi-nivo) for breast cancer was delayed two weeks (scheduled (b)(6) 2025)." - "husband lost work time while providing support during my hospitalization.".
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d8, d9, g6, h1, h2, h3, h4, h6, h8, h11.The medihoney gel (31815) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.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.The customer has indicated that the device was retained and may be returned for evaluation.It has not yet been returned at the time of this investigation.Should the product be returned, this complaint will be re-opened and assessed.At this time, the cause of the infection cannot be attributed to the medihoney device and is unconfirmed.A medical assessment was requested to integra's medical affairs department and the following was provided: "a female patient/customer with metastatic breast cancer reported developing a severe polymicrobial wound infection after approximately one month of using medihoney gel on a chest wall wound.She reports the initial symptoms of low-grade fever and generally not feeling good began around 26-27 days after initiating use of medihoney.She experienced fever (up to 102°f), pain, drainage, redness, and swelling, leading to two hospital admissions between (b)(6) 2025.Treatment included iv antibiotics (vancomycin, zosyn) and oral antibiotics (augmentin, ciprofloxacin).The patient was undergoing combination immunotherapy (¿ipi-nivo¿- ipilimumab and nivolumab combination immunotherapy treatments) for breast cancer." "given the patient¿s immunocompromised status and persistent chest wound (likely necrotic with the presence of continuous exudate), the wound environment was highly susceptible to bacterial colonization.Within this clinical context wound infection would be considered an anticipated event.The most probable source of contamination is endogenous (from the patient¿s own skin flora) or external contamination from hands, dressings, clothing, or healthcare-associated exposure." "medihoney is sterilized via gamma-irradiation after packaging eliminating viable bacteria, including mrsa, staphylococcus, and streptococcus species.The product is also naturally antimicrobial and has demonstrated antimicrobial activity in internal validation studies and a low risk of contamination over its labeled open-shelf life (4 months, single-patient multiple use).Manufacturing occurs in controlled cleanroom environments with strict contamination controls.Photos provided by the patient show no packaging defects.No packaging issues or defects were reported.There is no evidence to suggest a product defect or product contamination contributed to this adverse event.".
Event or Problem Description
N/a.

• Brand Name: MEDIHONEY GEL IN TUBE, 1.5 FL OZ FLIPCAP - STERILE
• Common Device Name: MEDIHONEY GEL
• 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 08540 ; 6099362319
• MDR Report Key: 23154496
• Report Number: 3005920706-2025-00022
• Device Sequence Number: 10146008
• Product Code: FRO
• UDI-Device Identifier: 10381780486886
• UDI-Public: 10381780486886
• Combination Product (Y/N): N
• PMA/510(K) Number: K101793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 31815
• Device Lot Number: 2450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005920706/08052025/R/00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown