FDA Adverse Event
Death
Summary report: N
BALLOON APPLICATOR KIT
MDR report key: 24740286
·
Received March 31, 2026
Report
- Report Number
- 3015232217-2026-00007
- Event Type
- Death
- Date Received
- March 31, 2026
- Report Date
- March 31, 2026
- Manufacturer
- ELEKTA SOLUTIONS AB
- Product Code
- JAD
- UDI-DI
- 00858012005311
- PMA / PMN Number
- K090914
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.
Description of Event or Problem · 0
THE CUSTOMER REPORTED A CASE OF POTENTIAL SEVERE TOXICITY. THE PATIENT WAS FOUND DECEASED SHORTLY AFTER SURGERY/IRRADIATION. IT IS ASSUMED THAT THE CAUSE MAY HAVE BEEN A PULMONARY EMBOLISM RATHER THAN A CEREBRAL EVENT; HOWEVER, THIS ULTIMATELY REMAINS UNCLEAR, AS AN AUTOPSY WAS DECLINED BY THE FAMILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191684 | BALLOON APPLICATOR KIT | BALLOON APPLICATOR, 3-4 CM SPHERICAL | JAD | ELEKTA SOLUTIONS AB | 720788 | 2435101 | 00858012005311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |