MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,foreign report with the FDA on 2019-05-15 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[145135535]
Zimmer biomet complaint (b)(4). The user facility is foreign; therefore a facility medwatch report will not be available. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145135536]
It was reported that the product hardened very quickly and did not become homogenous. The customer reported a problem when mixing the product during preparation of a therapeutic ear implant procedure. There was no significant surgical delay, the intended procedure was completed with another container of the same product, and this did not impact the outcome of the procedure. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00278 |
| MDR Report Key | 8612558 |
| Report Source | CONSUMER,DISTRIBUTOR,FOREIGN |
| Date Received | 2019-05-15 |
| Date of Report | 2019-08-12 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-08-08 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2019-05-15 |
| 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 | MR. ALAN MUNOZ |
| 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, STOMAL APPLIANCE, OSTOMY |
| Product Code | NEA |
| Date Received | 2019-05-15 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 402320 |
| Device Expiration Date | 2019-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-15 |