N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7876784
- MDR report key
- 7876784
- Report number
- 8020889-2018-00084
- Event key
- 0
- Event type
- 3
- Date received
- 2018-09-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- AVI KLUGER
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 203-203-2034
- 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 | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE | MALLINCKRODT MEDICAL | BYE | 125137 | 125137 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-09-14 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE DEVICE HAD MISSING COMPONENTS AND COULD NOT BE USED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.