MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2009-05-05 for BIB PTA CATHETER 420 manufactured by Numed, Inc..
[1191000]
Outer balloon would not inflate.
Patient Sequence No: 1, Text Type: D, B5
[8293222]
This catheter will not be returned to numed until it has been released by the health authority in the (b)(6). This is anticipated to be around (b)(4), 2009. Once the catheter has been received, the investigation will be performed and the results sent in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1318694-2009-00003 |
| MDR Report Key | 1431621 |
| Report Source | 01 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-04-30 |
| Date of Event | 2009-03-31 |
| Date Mfgr Received | 2009-04-03 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2010-05-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| Manufacturer Phone | 3153284491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIB PTA CATHETER |
| Generic Name | PTA CATHETER |
| Product Code | NVM |
| Date Received | 2009-05-05 |
| Model Number | 420 |
| Lot Number | BIB-2769 |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12967 US 12967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-05 |