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 SMALL CSM-S manufactured by .
[666902]
Physician reported that patient had a nasal surgery at the time the subject device was implanted. There were complications during nasal surgery, and patient developed nasal infection. Nasal infection was treated and appeared to resolve, but may have contributed to a later infection of the subject malar implants. The physician has treated the patient with clindamycin (p. O. ) and levaquin (p. O. ) when seen by physician's office in 2007. Symptoms seem to have resolved.
Patient Sequence No: 1, Text Type: D, B5
[7807727]
Reviewed device history records and sterilization records. Device history file review revealed no assignable cause for the reported event. Sterilization process was within specification, and there have been no other reports of infection involving this sterile lot. Product labeling warns of the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2007-00003 |
| MDR Report Key | 889603 |
| Report Source | 05 |
| Date Received | 2007-08-02 |
| Date of Report | 2007-08-02 |
| Date of Event | 2007-07-09 |
| Date Mfgr Received | 2007-07-09 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2007-08-10 |
| 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. 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 | 3 |
| Brand Name | COMBINED SUBMALAR SHELL SMALL |
| Generic Name | SUBMALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2007-08-02 |
| Catalog Number | CSM-S |
| Lot Number | 821193 |
| ID Number | NA |
| Device Expiration Date | 2011-08-31 |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 868737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-02 |