FDA Adverse Event
Injury
Summary report: N
INNOVATIVE MEDICAL TECHNOLOGIES INC.
MDR report key: 25193575
·
Received May 15, 2026
Report
- Report Number
- 3001451226-2026-00002
- Event Type
- Injury
- Date Received
- May 15, 2026
- Date of Event
- April 17, 2026
- Report Date
- May 5, 2026
- Manufacturer
- INNOVATIVE MEDICAL TECHNOLOGIES
- Product Code
- JKA
- UDI-DI
- 20612479206070
- PMA / PMN Number
- K220458
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A DEFINITIVE ROOT CAUSE COULD NOT BE CONFIRMED. A REVIEW OF QUALITY AND PRODUCTION DOCUMENTATION DID NOT IDENTIFY ANY ISSUES; THE RETAINED SAMPLES EXAMINED SHOWED NO NONCONFORMITY. THIS TYPE OF FAILURE HAS OCCURRED RARELY OVER TEN YEARS OF SALES. THIS FAILURE TYPE COULD HAPPEN DURING DEVICE ASSEMBLY IF THE SHIELD ISN'T COMPLETELY SNAPPED TOGETHER.
Description of Event or Problem · 0
SAFETY SPLITS INTO TWO HALVES- THE NEEDLES POPS BACK OUT. - UNSURE IF INJURY OR MEDICAL ATTENTION WAS NEEDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109567 | INNOVATIVE MEDICAL TECHNOLOGIES INC. | PUSH BUTTON BLOOD COLLECTION SET | JKA | INNOVATIVE MEDICAL TECHNOLOGIES | 250815M | 20612479206070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |