DERMACLOSE
Received May 27, 2025
Report 1416980-2025-03062 · MDR key 22093397
Device
Generic name
System, Skin Closure
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Wound Dehiscence
- Wound Dehiscence
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER RESPONDED ¿6-15% OF PATIENTS EXPERIENCE WOUND DEHISCENCE AFTER PRIMARY SURGICAL CLOSURE¿ WHEREIN DERMACLOSE WAS REMOVED. ADDITIONALLY, THE RESPONDENT STATED, ¿THESE ARE TYPICALLY HIGH RISK TO BEGIN WITH; SO UNCLEAR WHETHER THE WOUND HEALING FAILURE WAS DUE TO DERMACLOSE OR THE SUBSTRATE¿. THIS EVENT LIKELY REQUIRED MEDICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION WAS NOT ABLE TO BE OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.