*

Report

• Report Number: 8041108-2008-00001
• Event Type: Injury
• Date Received: March 29, 2008
• Manufacturer: SIAM SEMPERMED CORP. LTD.
• Product Code: FMC
• PMA / PMN Number: K060753
• Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

NITRILE GLOVES FROM SAME LOT WERE TESTED FOR ALLERFENIC PROTEINS BY OUTSIDE LAB AFTER INCIDENT REPORTED TO MFR. NO ALLERGENIC PROTEINS WERE DETECTED. AS A RESULT, CAUSE OF NURSE'S REACTION IS UNK AND MAY NOT BE GLOVE RELATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	*	*	FMC	SIAM SEMPERMED CORP. LTD.	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 3

• Allergic reaction
• Anaphylaxis
• Hospitalization required

Source type · 1

• Distributor

Type of report · 1

• Initial submission