N
Patient 1
MAUDE MDR 6485214
- MDR report key
- 6485214
- Report number
- 6485214
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-01-03
- Date received
- 2017-04-12
- 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#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INTRANASAL MUCOSAL ATOMIZATION DEVICE | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) | TELEFLEX MEDICAL | CCQ | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-12 | 0 |
Event Narratives#
D
Patient 1
SAFETY CONCERN REGARDING PRODUCT RECALL AND THERE IS NO OTHER OPTION FOR USE. IN THIS PARTICULAR PATIENT'S CASE, FAILURE OF THE DEVICE LED TO PATIENT EXPERIENCING SEIZURE. NASAL ATOMIZED VERSE WAS NOT ABLE TO BE PROVIDED DUE TO UNAVAILABILITY OF NASAL ATOMIZER. NO NON-RECALLED ATOMIZER COULD BE LOCATED AND PATIENT'S SEIZURE RESOLVED ON ITS OWN WITHOUT PHARMACEUTICAL INTERVENTION THAT WOULD HAVE LIKELY SHORTENED THE DURATION. MANUFACTURER RESPONSE FOR NASAL ATOMIZER, LMA MAD NASAL INTRANASAL MUCOSAL ATOMIZATION DEVICE (PER SITE REPORTER): NO REPLACEMENT OPTIONS HAVE BEEN IDENTIFIED OR PROVIDED TO DATE.