FDA Adverse Event
Injury
Summary report: N
CIRCUMCISION TRAY 1.3 CM BELL
MDR report key: 17450215
·
Received August 3, 2023
Report
- Report Number
- 3004122598-2023-00006
- Event Type
- Injury
- Date Received
- August 3, 2023
- Date of Event
- July 5, 2023
- Report Date
- August 3, 2023
- Manufacturer
- CENTURION
- Product Code
- OHG
- UDI-DI
- 10195327313760
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PER THE FACILITY "THE PROVIDER HAD AN ISSUE WITH BABIES BLEEDING WITH CLOTS AFTER USING THE DEVICE FOR CIRCUMCISION". SAMPLE REQUESTED TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 0
PER THE FACILITY "THE PROVIDER HAD AN ISSUE WITH BABIES BLEEDING WITH CLOTS AFTER USING THE DEVICE FOR CIRCUMCISION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1470206 | CIRCUMCISION TRAY 1.3 CM BELL | OHG | CENTURION | 10195327313760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |