N
Patient 1
MANUFACTURER REF# (B)(4). COMMON NAME: (B)(6). SIMILAR TO DEVICE UNDER PMA/510(K) P100028. INVESTIGATION IS STILL IN PROGRESS.
MAUDE MDR 9542623
- MDR report key
- 9542623
- Report number
- 3002808486-2019-01984
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-03
- Date received
- 2020-01-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. THOMAS HESSNER KIRK
- Address
- SANDET 6 BJAEVERSKOV DK-46 DA
- Phone
- 568-568-5686
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT | WILLIAM COOK EUROPE | NIN | FORX4-14-135-7-16 | E3734959 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-03 | 0 |
Event Narratives#
D
Patient 1
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE BALLOON BURST WHEN IT WAS INFLATED TO 10 ATM. PATIENT OUTCOME: UNKNOWN.