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 .
[671621]
This is the same pt that was reported on medwatch #2028924-2007-00001. This report is for the second event on this pt. Physician reported that after device was implanted, the pt had continuing problems with inflammatory process/infection. No organism has been cultured to date. The physician has treated the pt with clindamycin (po), levaquin (po), augmentin (po), and cipro (po). At the time of last contact with physician, symptoms had not yet resolved.
Patient Sequence No: 1, Text Type: D, B5
[7905667]
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 | 2028924-2007-00002 |
| MDR Report Key | 889602 |
| 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 | 2007-03-01 |
| 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 | 822589 |
| ID Number | NA |
| Device Expiration Date | 2012-01-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 868477 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-02 |