CIRCLAMP W/1.1CM BELL (ST)
Report
- Report Number
- 1824619-2025-00014
- Event Type
- Injury
- Date Received
- August 5, 2025
- Date of Event
- May 31, 2025
- Report Date
- August 18, 2025
- Manufacturer
- CENTURION MEDICAL PRODUCTS, LP
- Product Code
- HFX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UPDATE TO H6: INVESTIGATION FINDINGS. UPDATE TO H6: INVESTIGATION CONCLUSIONS.
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, AN INFANT UNDERWENT CIRCUMCISION AND EXPERIENCED "PROLONGED BLEEDING," ULTIMATELY RESULTING IN "THE RAPID RESPONSE TO NICU." UROLOGY PLACED A PRESSURE DRESSING WHICH ALLOWED THE BLEEDING TO "ABATE." ACCORDING TO THE CUSTOMER, THE INFANT'S STAY WAS POTENTIALLY PROLONGED AS IT "WILL NEED TO STAY AT LEAST 24 HOURS PAST DRESSING PLACEMENT." DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, AN INFANT UNDERWENT CIRCUMCISION AND EXPERIENCED "PROLONGED BLEEDING," ULTIMATELY RESULTING IN "THE RAPID RESPONSE TO NICU."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1765642 | CIRCLAMP W/1.1CM BELL (ST) | HFX | CENTURION MEDICAL PRODUCTS, LP | 2025040901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |