D
Patient 1
BALLOON BURST.
MAUDE MDR 1968538
- MDR report key
- 1968538
- Report number
- 1318694-2010-00014
- Event key
- 0
- Event type
- 3
- Date received
- 2010-12-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- NICHELLE LAFLESH
- Address
- 2880 MAIN ST. HOPKINTON NY 12965 US
- Phone
- 315-315-3153
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TEARDUCT CATHETER | DACRYOCYSTOPLASTY CATHETER | NUMED, INC. | HNW | 352 | TD100 | TD-0044 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-12-23 | 0 |
Event Narratives#
N
Patient 1
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.