MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-25 for UNKNOWN manufactured by Acclarent, Inc..
[26825946]
Acclarent products of an unknown type were used during the procedure, but it is not known if traditional surgical instruments may have been used as well. It is unknown if the patient had a history of seizures or was on anti-seizure medication. It is also unknown whether the seizure may have been caused by an anesthetic or sedation given to the patient. No acclarent devices are available to be returned for evaluation as they were discarded by the user facility. If additional information is received regarding this report, a supplemental report will be filed. Acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
[26825947]
Acclarent was informed of an event in which a patient was said to have had a seizure following a balloon sinuplasty procedure performed in the physician's office. Acclarent products of an unidentified type were said to have been used during the procedure. It is not known if other non-acclarent devices were used as well. The physician reported that the balloon sinuplasty procedure went as planned with no complications. At an unknown period of time following the completion of the procedure, the patient was said to have had a seizure and was taken to the hospital. It is unknown what treatment, if any, was provided to the patient. Acclarent has attempted to contact the reporting physician to obtain additional information related to the event, but has received no further details of the occurrence, or the status of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2015-00013 |
| MDR Report Key | 5106167 |
| Date Received | 2015-09-25 |
| Date of Report | 2015-08-28 |
| Date of Event | 2015-08-28 |
| Date Mfgr Received | 2015-08-28 |
| Date Added to Maude | 2015-09-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | IZABEL NIELSON |
| Manufacturer Street | 1525-B O |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506877492 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | KAM |
| Date Received | 2015-09-25 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 1525-B O?BRIEN DR. MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-09-25 |