FDA Adverse Event
Malfunction
Summary report: N
3005770977-2018-00007
MDR report key: 8030141
·
Received November 1, 2018
Report
- Report Number
- 3005770977-2018-00007
- Event Type
- Malfunction
- Date Received
- November 1, 2018
- Report Date
- November 1, 2018
- PMA / PMN Number
- K063671
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DISTRIBUTOR (AN INTITIAL REPORTER) REPORTED THAT THE BROKEN FRAME (RING) OF THE MESH OF RBOUND HRD WAS EXPLANTED AND THE MESH WAS LEFT INSIDE SO AS TO KEEP THE HERNIA REPAIRED.
Description of Event or Problem · 1
THE PATIENT COMPLAINED OF PAIN. IT WAS REPORTED THAT THE FRAME (ALSO KNOWN AS A RING) OF THE MESH OF THE HERNIA REPAIR DEVICE, REBOUND HRD, WAS BROKEN.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |