NI
Received May 19, 2021
Report 1416980-2021-03059 · MDR key 11852076
Device
Generic name
System, Skin Closure
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
NI
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR
- Nerve Damage
- Nerve Damage
Narrative
Additional Manufacturer Narrative
THE REPORTED PRODUCT IS AN UNKNOWN BAXTER DERMA CLOSE PRODUCT. LITERATURE ARTICLE: MACKAY, B., J., DARDANO, A., N., KLAPPER, A., M., PAREKH, S., G., SOLIMAN, M., Q., AND VALERIO I., L. ¿MULTIDISCIPLINARY APPLICATION OF AN EXTERNAL TISSUE EXPANDER DEVICE TO IMPROVE PATIENT OUTCOMES: A CRITICAL REVIEW¿. ADVANCES IN WOUND CARE. 2020 SEP;9(9):525-538. DOI: 10.1089/WOUND.2019.1112. EPUB 2020 FEB 19. 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 STUDY WAS PERFORMED IN WHICH A PATIENT UNDERWENT AN ANTEROLATERAL THIGH (ALT) FLAP WITH USE OF DERMACLOSE FOR CONTINUOUS EXTERNAL TISSUE EXPANSION. IT WAS REPORTED AFTER USE, THE PATIENT EXPERIENCED LIMITED KNEE EXTENSION. IT WAS REPORTED THE FEMORAL NERVE APPEARED INTACT; HOWEVER, INTRAMUSCULAR ELECTROMYOGRAPHY SHOWED MINIMAL NERVE FUNCTION. 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.