MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-03-28 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[142538716]
Zimmer biomet complaint (b)(4). Lot number - possible lot numbers are: 016570, 582090, 402320. Expiration date - lot 016570: june 2, 2020; lot 582090: may 2, 2020; lot 402320: november 1, 2019. Health professional - initial reporter has an email associated with a hospital. Occupation - initial reporter has an email associated with a hospital, no other information. Initial reporter also sent report to fda - the user facility is foreign; therefore a facility medwatch report will not be available. Report source: (b)(6). Device manufacture date - lot 016570: june 2, 2018; lot 582090: may 2, 2018; lot 402320: november 1, 2017. Additional narratives/data - 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
[142538737]
It was reported that the customer has had various problems with the mix. Either the mix has been too loose or too dry but still not hardened after 10 min. Up to two times the customer has used up to 3-4 products to get it right while the patient has been in narcosis. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00189 |
| MDR Report Key | 8460613 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-03-28 |
| Date of Report | 2019-07-30 |
| Date Mfgr Received | 2019-07-29 |
| Date Added to Maude | 2019-03-28 |
| 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 | 9043677142 |
| 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 | 2019-03-28 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-28 |