FDA Adverse Event
Injury
Summary report: N
KIRSHNER WIRE, K-WIRE
MDR report key: 7637964
·
Received June 25, 2018
Report
- Report Number
- MW5078069
- Event Type
- Injury
- Date Received
- June 25, 2018
- Date of Event
- April 1, 1954
- Report Date
- June 21, 2018
- Manufacturer
- UNK
- Product Code
- HTY
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NM, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
NO MEDICAL RECORDS AVAILABLE. HOSPITAL CLOSED FOR YEARS. UPON A REAR END ACCIDENT I HAVE BEEN THROUGH PAIN SUFFERING. MANY MDS UNABLE TO DIAGNOSE PROBLEM, NOT VISIBLE. AFTER PLASTICS ENT AND RESEARCH FOUND, CT CONFIRMED, FACIAL AND/OR SINUS REPLACEMENT WITH K WIRE, PROBABLY AT BIRTH. I AM NOW ALMOST (B)(6) AND THIS HAS BEEN A NIGHTMARE. I SPENT MY ENTIRE WORKING LIFE AS A (B)(6). PLEASE HELP ME LOCATE ANY INFO THE FDA MIGHT HAVE. (B)(6). THANK YOU IN ADVANCE. K WIRE USED FOR ENT SURGERY IN 1954.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475142 | KIRSHNER WIRE, K-WIRE | PIN FIXATION, SMOOTH | HTY | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Congenital Anomaly| R| S |