FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 38693
·
Received September 5, 1996
Report
- Report Number
- 38693
- Event Type
- Injury
- Date Received
- September 5, 1996
- Date of Event
- September 2, 1996
- Report Date
- September 5, 1996
- Manufacturer
- SKLAR INSTRUMENTS
- Product Code
- HFX
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING ELECTIVE CIRCUMCISION OF ONE-DAY OLD BABY, TIP OF GLANS PENIS WITH MEATUS WAS ACCIDENTALLY AMPUTATED. UROLOGY AND PLASTIC SURGERY CONSULTS WERE OBTAINED IMMEDIATLEY. BABY WAS TAKEN TO SURGERY FOR RE-ATTACHMENT OF PENILE TISSUE AND REANASTOMOSIS OF THE URETHRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | MOGEN CLAMP | HFX | SKLAR INSTRUMENTS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DAY | Required Intervention |