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