MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-04-24 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[73512137]
(b)(4). Review of the device history records shows the lot was released with no recorded anomaly or deviation. The package insert contains mixing instructions. The product was discarded by the hospital and therefore will not be returned for an evaluation. 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
[73512138]
It was reported the otomimix would not solidify during prep; after 5-7 minutes the mixture was not solid. The surgeon used another box and it worked fine. There was no delay or patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00303 |
| MDR Report Key | 6515397 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-04-24 |
| Date of Report | 2017-04-21 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2016-02-02 |
| Date Added to Maude | 2017-04-24 |
| 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 | 2G OTOMIMIX |
| Generic Name | CEMENT, EAR, NOSE AND THROAT |
| Product Code | NEA |
| Date Received | 2017-04-24 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 889840 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2018-02-02 |
| 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 | 2017-04-24 |