FDA Adverse Event
Malfunction
Summary report: N
MGB
MDR report key: 5095097
·
Received September 22, 2015
Report
- Report Number
- 3004939290-2015-00441
- Event Type
- Malfunction
- Date Received
- September 22, 2015
- Report Date
- September 2, 2015
- Manufacturer
- CARDINAL HEALTH
- Product Code
- MGB
- PMA / PMN Number
- P040044
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 1
THE FOLLOWING INFORMATION WAS REPORTED: THE DOCTOR STATED THAT HE USED A MYNX VASCULAR CLOSURE DEVICE IN A PATIENT AND HAD TO HOLD MANUAL PRESSURE FOR LONGER THAN USUAL (LESS THAN 15 MINUTES). HE WOULD NOT ELABORATE ON THE ISSUE AND DID NOT WANT TO QUALIFY THE EVENT AS A FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625071 | MGB | MGB | CARDINAL HEALTH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |