FDA Adverse Event Other Summary report: N

MILTEX

MDR report key: 119584 · Received September 11, 1997

Report

Report Number
2431021-1997-00009
Event Type
Other
Date Received
September 11, 1997
Date of Event
September 3, 1997
Report Date
September 11, 1997
Manufacturer
MILTEX INSTRUMENT CO.
Product Code
KYZ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
WI, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

SYRINGE CAME APART WHILE IN USE, LACERATING THE PATIENTS EARDRUM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MILTEX EAR SYRINGE, 4 OZ W/SHIELD KYZ MILTEX INSTRUMENT CO. 19-385 UNK

Patients

Seq Age Sex Outcome Treatment
1 79 YR Required Intervention