UNKNOWN STEEL SUTURE
Received Jun 23, 2025
Report 9612501-2025-01594 · MDR key 22312033
Device
Generic name
Suture, Nonabsorbable, Steel, Monofilament And
Manufacturer
Davis & Geck Caribe LtdModel number
UNKNOWN STEEL SUTURECatalog number
UNKNOWN STEEL SUTURE
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Wound Dehiscence
- Post Operative Wound Infection
- Wound Dehiscence
- Post Operative Wound Infection
Narrative
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
ACCORDING TO THE REPORTER, POST-OPERATIVELY, WOUND DEHISCENCE AND WOUND INFECTION WERE IDENTIFIED.