MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-02 for COMBINED SUBMALAR SHELL MEDIUM CSM-M manufactured by .
[666775]
This is the same pt that was reported on medwatch #2028924-2007-00002. This report is for the first event on this pt. Physician reported that device was explanted and replaced approx 6 weeks after implantation due to displacement.
Patient Sequence No: 1, Text Type: D, B5
[7807726]
Reviewed device history records. Device history file review revealed no assignable cause for the reported event. Product labeling warns of the possibility of displacement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2007-00001 |
| MDR Report Key | 889601 |
| Report Source | 05 |
| Date Received | 2007-08-02 |
| Date of Report | 2007-08-02 |
| Date of Event | 2007-06-13 |
| Date Mfgr Received | 2007-07-09 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2007-08-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN MEADE |
| Manufacturer Street | 6025 NICOLLE ST STE 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 | 3 |
| Brand Name | COMBINED SUBMALAR SHELL MEDIUM |
| Generic Name | SUBMALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2007-08-02 |
| Model Number | NA |
| Catalog Number | CSM-M |
| Lot Number | 822020 |
| ID Number | NA |
| Device Expiration Date | 2011-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 868468 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-02 |