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 |