FDA Adverse Event
Injury
Summary report: N
MEDLINE KONIG MOGEN CIRCUMCISION CLAMPS
MDR report key: 19499173
·
Received June 7, 2024
Report
- Report Number
- MW5155995
- Event Type
- Injury
- Date Received
- June 7, 2024
- Date of Event
- May 18, 2024
- Report Date
- June 5, 2024
- Manufacturer
- MEDLINE INDUSTRIES, LP - NORTHFIELD
- Product Code
- HFX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WHEN MOGEN PULLED BACK TO ADJUST PLACEMENT, THERE APPEARED TO BE A LACERATION ON THE LEFT SIDE OF THE NEWBORNS PENIS DURING CIRCUMCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184243 | MEDLINE KONIG MOGEN CIRCUMCISION CLAMPS | CLAMP, CIRCUMCISION | HFX | MEDLINE INDUSTRIES, LP - NORTHFIELD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Male | Required Intervention |