N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9686941
- MDR report key
- 9686941
- Report number
- 2936999-2020-00105
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-01
- Date received
- 2020-02-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- AVI KLUGER
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 303-303-3035
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SHILEY | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) | COVIDIEN AG JUAREZ (MMJ) | BTO | 8PERC | 8PERC | 19D0646JZX | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-10 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE FIRST ITEM BALLOON WAS BROKEN OR DAMAGED AND THE 2ND ITEM BALLOON DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.