FDA Adverse Event
Other
Summary report: N
SIMPSON LIUKART
MDR report key: 245402
·
Received October 18, 1999
Report
- Report Number
- MW1017352
- Event Type
- Other
- Date Received
- October 18, 1999
- Date of Event
- May 20, 1999
- Report Date
- October 18, 1999
- Manufacturer
- SKLAR INSTRUMENTS CO.
- Product Code
- HDA
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SILASTIC/FORCEPS DELIVERY COMPLICATED BY SUBGALEAL HEMATOMA. NO ADVERSE OUTCOME TO PT. NO NEUROLOGIC SEQUELA. STABLE HEMATOCRIT THROUGHOUT HOSPITALIZATION WITHOUT INTERVENTION. EVENT COMMUNICATED TO REPORTING MANAGER 10/12/99.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPSON LIUKART | DELIVERY FORCEPS | HDA | SKLAR INSTRUMENTS CO. | 14" FORCEPS | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DAY | Other |