FDA Adverse Event Injury Summary report: N

SALINE TESTICULAR, LARGE

MDR report key: 480677 · Received August 29, 2003

Report

Report Number
2125050-2003-00361
Event Type
Injury
Date Received
August 29, 2003
Date of Event
July 30, 2003
Report Date
August 18, 2003
Manufacturer
MENTOR CORP. - MINNESOTA DIVISI
Product Code
FAF
Removal / Correction Number
NA
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

DESCRIBE EVENT OR PROBLEM: THERE WAS LEAKAGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SALINE TESTICULAR, LARGE TESTICULAR PRODUCT FAF MENTOR CORP. - MINNESOTA DIVISI 450-1329 789535

Patients

Seq Age Sex Outcome Treatment
1 44 YR Hospitalization| R