FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 12615600
·
Received October 12, 2021
Report
- Report Number
- 1721504-2021-00070
- Event Type
- Malfunction
- Date Received
- October 12, 2021
- Date of Event
- May 13, 2021
- Report Date
- October 2, 2021
- Manufacturer
- MERIT MEDICAL SYSTEMS INC.
- Product Code
- OEQ
- UDI-DI
- 10854339004034
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE COMPLAINT IS CONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED HOWEVER, IT IS ATTRIBUTED TO THE MANUFACTURING PROCESS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.
Description of Event or Problem · 1
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1512134 | MERIT CUSTOM KIT | CUSTOM KIT | OEQ | MERIT MEDICAL SYSTEMS INC. | 85-018-E140S | H1960772 | 10854339004034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |