MalfunctionMMP
EQUIPMENT COVER
Received Jun 11, 2019 · Event occurred Jun 4, 2019
Report MW5087284 · MDR key 8692360
Device
Generic name
Cover, Barrier, Protective
Manufacturer
Argon Medical Devices, Inc.Catalog number
396009
Lot number
11256726
Product problems
- Material Puncture/Hole
Patient
72 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
TEAR/HOLE PRESENT UPON OPENING EQUIPMENT COVER. FDA SAFETY REPORT ID # (B)(4).