MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2010-12-23 for TEARDUCT CATHETER 352 TD100 manufactured by Numed, Inc..
[1898733]
Balloon burst.
Patient Sequence No: 1, Text Type: D, B5
[8935346]
Longitudinal balloon burst was confirmed. This is usually consistent with inflation above the rated burst pressure, however, the report states that it burst right at the rated burst pressure. The catheter is rated for 14atm. The device from the controlled inventory was tested for rated burst pressure. It burst at 18atm which is well above the labeled rated burst pressure. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1318694-2010-00014 |
| MDR Report Key | 1968538 |
| Report Source | 01,06,08 |
| Date Received | 2010-12-23 |
| Date of Report | 2010-12-23 |
| Date Mfgr Received | 2010-11-26 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2011-05-03 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN ST. |
| 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 | TEARDUCT CATHETER |
| Generic Name | DACRYOCYSTOPLASTY CATHETER |
| Product Code | HNW |
| Date Received | 2010-12-23 |
| Returned To Mfg | 2010-12-10 |
| Model Number | 352 |
| Catalog Number | TD100 |
| Lot Number | TD-0044 |
| Device Expiration Date | 2015-03-30 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN ST. HOPKINTON NY 12965 US 12965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-23 |