MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-10 for COMBINED SUBMALAR SHELL IMPLANT CSM-L manufactured by Implantech Associates Inc..
[25822151]
Method: dhr review. Labeling addresses complications associated with all surgical procedures, including poor would healing, hematoma, serous fluid accumulation, nerve damage or irritation, neuralgia, etc. Results: anticipated or known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2015-00005 |
| MDR Report Key | 5073834 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-10 |
| Date of Report | 2015-09-09 |
| Date of Event | 2014-11-03 |
| Date Mfgr Received | 2015-08-11 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-09-14 |
| 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 | CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE ST. SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMBINED SUBMALAR SHELL IMPLANT |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2015-09-10 |
| Model Number | NA |
| Catalog Number | CSM-L |
| Lot Number | 854905 |
| Device Expiration Date | 2019-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES INC. |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-10 |