FDA Adverse Event Other Summary report: N

1030451-2012-00002

MDR report key: 3118743 · Received April 30, 2012

Report

Report Number: 1030451-2012-00002
Event Type: Other
Date Received: April 30, 2012
Product Code: LRS
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ON 04/03/2012, MEDICAL ACTION INDUSTRIES (MAI) (B)(4) FACILITY RECEIVED FROM (B)(6) RN OF (B)(6), A COPY MEDWATCH REPORT WHICH WAS THEN FORWARDED TO MAI COMPLAINT UNIT (B)(4) AND RECEIVED ON 04/13/2012. MAI HAS NOT PREVIOUSLY RECEIVED THIS COMPLAINT AND ASSIGNED COMPLAINT # (B)(4). (B)(6) WAS CONTACTED FOR FURTHER INFORMATION AND FORWARDED A COPY OF THE PHOTOGRAPH OF THE PATIENT'S ARM WITH A SUPERFICIAL LACERATION, SHE ALSO STATED THAT SHE HAD THE ORIGINAL CHLORAPREP APPLICATOR AND PACKAGING. MAI CONTACTED CAREFUSION THE MANUFACTURER OF THE COMPLAINED CHLORAPREP AND ISSUED SCAR #(B)(4), ARRANGEMENTS WERE ALSO MADE FOR (B)(6) TO MAIL THE COMPLAINED SAMPLE DIRECTLY TO CAREFUSION, ATTENTION (B)(4) - FRONT DESK, FOR THEIR EVALUATION. THE SAMPLE WAS RECEIVED BY CAREFUSION ON APRIL 20TH 2012. CAREFUSION ISSUED COMPLAINT #(B)(4). CAREFUSION'S RESPONSE TO SCAR # (B)(4) WILL BE REVIEWED AND KEPT ON FILE ONCE RECEIVED. IN ADDITION, THIS OCCURRENCE HAS BEEN ENTERED INTO MAI'S FORMAL COMPLAINT SYSTEM IN WHICH DEFECT TRENDS ARE CLOSELY MONITORED.

Description of Event or Problem · 1

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1			LRS

Patients

Seq	Age	Sex	Outcome	Treatment
1