InjuryMDA
SILAGEN ABDOMINAL STRIP
Received Jan 30, 2020 · Event occurred Jan 16, 2020
Report MW5092668 · MDR key 9653832
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Newmedical Technology, Inc.Model number
ABDOMINAL STRIPProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
42 YR
- Purulent Discharge
- Reaction
- Tissue Breakdown
- Purulent Discharge
- Reaction
- Tissue Breakdown
Narrative
Description of Event or Problem
THE SILAGEN TAPE CAUSED A REACTION ON MY SKIN AND THE INCISION BEGAN OOZING AND THE SKIN WAS PEELING OFF. FDA SAFETY REPORT ID# (B)(4).