MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-01 for OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[68673763]
(b)(4). Review of device history records show the lot released with no recorded anomaly or deviation. The warnings in the package insert state this type of event can occur. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[68673764]
It was reported the surgeon performed a cochlear implant procedure. The first box of otomimix hardened too fast to be used. The second box of otomimix was mixed and placed in the ear but did not set. The mixture was scooped out of the patient's ear. No adverse outcome for the patient was reported. The procedure was completed using a different brand of cement. Additional details have been requested, however no response has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00133 |
| MDR Report Key | 6370010 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-01 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-02-01 |
| Device Manufacturer Date | 2016-06-06 |
| Date Added to Maude | 2017-03-01 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTOMIMIX |
| Generic Name | CEMENT, EAR, NOSE AND THROAT |
| Product Code | NEA |
| Date Received | 2017-03-01 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 392700 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2018-06-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-01 |