NONE

Report

• Report Number: MW5016175
• Event Type: Other
• Date Received: May 26, 2010
• Report Date: May 25, 2010
• Product Code: FWM
• Report Source: Voluntary report
• Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION 803.22, WE WISH TO INFORM YOU OF AN ADVERSE EVENT REPORT ASSOCIATED WITH ANOTHER MANUFACTURER'S DEVICE WHICH HAS BEEN RECEIVED AT ALLERGAN INC. (B) (6). THE FOLLOWING INFO WAS PROVIDED. (B) (6). IMPLANT PHYSICIAN: UNK. EXPLANT PHYSICIAN: DR. (B) (6). ALLEGED EVENT: DOCTOR REPORTED REPLACING RIGHT SIDE DEVICE DUE TO DEFLATION. PER LAB ANALYSIS: MANUFACTURER OF THE DEVICE WAS NOT ALLERGAN MEDICAL. THERE IS NO COMPLAINT AGAINST AN ALLERGAN MEDICAL DEVICE. IMPLANT DATE: UNK. EXPLANT DATE: (B) (6) 2010. IF I MAY BE OF ANY FURTHER ASSISTANCE IN THIS MATTER, (B) (6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		NONE	FWM

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Code Available

Product problems · 1

• Inflation Problem

Type of report · 1

• Initial submission