MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-03 for FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT FORX4-14-135-7-16 manufactured by William Cook Europe.
[184467653]
Manufacturer ref# (b)(4). Common name: (b)(6). Similar to device under pma/510(k) p100028. Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[184467654]
Description of event according to initial reporter: the balloon burst when it was inflated to 10 atm. Patient outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2019-01984 |
| MDR Report Key | 9542623 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-03 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-06-11 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. THOMAS HESSNER KIRK |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-4632 |
| Manufacturer Phone | 56868686 |
| Manufacturer G1 | WILLIAM COOK EUROPE |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-4632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT |
| Product Code | NIN |
| Date Received | 2020-01-03 |
| Catalog Number | FORX4-14-135-7-16 |
| Lot Number | E3734959 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |