NI
Received Nov 8, 2023 · Event occurred Oct 16, 2023
Report 1416980-2023-05775 · MDR key 18094148
Device
Generic name
System, Skin Closure
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
GEM204010-K
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Female
- Necrosis
- Necrosis
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
A PATIENT UNDERWENT A FASCIOTOMY ON THE LEFT FOREARM WITH TWO DERMACLOSE DEVICES. IT WAS REPORTED THAT 11 DAYS POST-OPERATIVE, THE PATIENT EXPERIENCED SKIN NECROSIS. IT WAS FURTHER REPORTED THE EVENT WAS DISCOVERED ¿AS A RESULT OF DERMACLOSE ANCHORS¿. THE CAUSE OF THE EVENT WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.