FDA Adverse Event Malfunction Summary report: N

ALLEGIANCE SILICONE COATING

MDR report key: 1008551 · Received March 6, 2008

Report

Report Number: 9611710-2008-00001
Event Type: Malfunction
Date Received: March 6, 2008
Date of Event: November 30, 2007
Report Date: March 5, 2008
Manufacturer: UNOMEDICAL SDN BHD
Product Code: KOD
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT COULD NOT BE CONFIRMED AS THE AFFECTED PRODUCT WAS NOT RETURNED FOR EVAL. REVIEWING OF BATCH RECORD OR EVALUATION OF RETAINED SAMPLE WAS ALSO NOT POSSIBLE AS THE ACTUAL LOT # INVOLVED WAS UNK. SINCE THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED, FURTHER INVESTIGATION IN DETERMINING AND CONFIRMING THE ROOT CAUSE OF PRODUCT FAILURE COULD NOT BE CARRIED OUT. SHOULD THE DEVICE BE RECEIVED AT THE LATER STAGE, QA WILL RE-OPEN THIS FILE FOR INVESTIGATION AND WILL FILE AN ADDENDUM TO THIS REPORT IF REQUIRED.

Description of Event or Problem · 1

BALLOON WOULD NOT DEFLATE. NO INJURY BUT PT TAKEN TO EMERGENCY ROOM (INFO REC'D BY UNOMEDICAL ON 12/05/2007). UROLOGIST PROBED WITH THE NEEDLE THRU THE VAGINA TO RELIEVE PRESSURE OF THE BULB. (INFO REC'D BY UNOMEDICAL ON THE 03/01/2008). NOTE: CARDINAL HEALTH FORWARD THE COMPLAINT TO UNOMEDICAL INC. USA ON THE 12/03/2007 AND UNOMEDICAL RECEIVED AND ACKNOWLEDGED THE COMPLAINT ON THE 12/05/2007. SINCE THERE IS NO INJURY, LACK OF INFO AND NO SAMPLE THAT CAN ENABLE INVESTIGATION WHEN THE COMPLAINT WAS INITIALLY LODGED, NO MDR REPORT WAS GENERATED. UPON RECEIPT OF FURTHER INFO ON THE 03/01/2008, UNOMEDICAL REVIEW THE CASE AGAIN AND HAVE DECIDED TO FILE THIS INCIDENT REPORT (MDR) RETROSPECTIVELY. CARDINAL HEALTH COMPLAINT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALLEGIANCE SILICONE COATING	SILICONIZED FOLEY CATHETER	KOD	UNOMEDICAL SDN BHD	PE518	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention