FDA Adverse Event
Malfunction
Summary report: N
MEDIHONEY GEL
MDR report key: 3149097
·
Received May 31, 2013
Report
- Report Number
- MW5030414
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Report Date
- May 20, 2013
- Manufacturer
- DERMA SCIENCES
- Product Code
- FRO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOUR OUT OF 4 COMMERCIAL LOTS OF MEDIHONEY GEL WERE TESTED FOR THE PRESENCE OF ENDOTOXIN AND FOUND TO HAVE LEVELS IN EXCESS OF THE USP LIMIT OF 0.5 EU/ML FOR DEVICES THAT DIRECTLY OR INDIRECTLY CONTACT THE CARDIOVASCULAR OR LYMPHATIC SYSTEM. THESE LOTS WERE SUBMITTED TO AN INDEPENDENT LABORATORY FOR CONFIRMATORY TESTING. RESULTS CONFIRM LEVELS THAT ARE 1,000-2,000 TIMES THE UPPER ACCEPTANCE LIMIT. WHEREAS THE PRODUCT IS USED IN DIRECT REPEATED APPLICATION TO OPEN WOUNDS, INCLUDING IN NEONATES AND THE ELDERLY, THESE HIGHLY ELEVATED ENDOTOXIN LEVELS APPEAR HAZARDOUS. EXACERBATED WOUND INFLAMMATION, DELAYED HEALING, AND IATROGENIC SYSTEMIC INFLAMMATORY RESPONSES MAY RESULT FROM USE OF AFFECTED LOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240354 | MEDIHONEY GEL | MEDICAL GRADE HONEY DRESSING | FRO | DERMA SCIENCES | 1133 | ||
| 240355 | MEDIHONEY GEL | MEDICAL GRADE HONEY DRESSING | FRO | DERMA SCIENCES | 1213 | ||
| 240356 | MEDIHONEY GEL | MEDICAL GRADE HONEY DRESSING | FRO | DERMA SCIENCES | 1225 | ||
| 240478 | MEDIHONEY GEL | MEDICAL GRADE HONEY DRESSING | FRO | DERMA SCIENCES | 1219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |