MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-10 for CONFORM BINDER SUBMALAR, MEDIUM CBSM-M manufactured by Implantech Associates, Inc..
[15783602]
The physician reported that pt presented 12 days after implantation with malar implants and complained of swelling and drainage on right side, and an odd taste in her mouth. A culture was taken. Pt was treated with oral clindamycin, then switch to oral cipro when the culture came back positive for enterobacter aerogenes. Subsequently, pt rec'd 10 course of oral keflex. Pt continued to complain of an odd taste in her mouth. Six weeks post-op, pt was asymptomatic and cultures were negative. Pt saw a dentist who could not identify a problem. Pt saw an infectious disease specialist who prescribed a different antibiotic, but pt discontinued use due to stomach upset. At two months post-op, reporting physician felt pt to be asymptomatic. Pt continued to complain of odd taste in mouth, which was felt to be possible drainage although they found no physical signs of drainage. On (b)(6) 2012, the right side device was explanted. Culture was negative.
Patient Sequence No: 1, Text Type: D, B5
[15855653]
Method: reviewed device history records, sterilization records, and product labeling. Results: device history records review revealed no assignable cause for the reported event. The sterilization process was within specified parameters, and there have been no other reports of infection involving this sterile lot. (total of 945 products. ) product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2012-00001 |
| MDR Report Key | 2577892 |
| Report Source | 05 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-02-07 |
| Date Mfgr Received | 2012-04-10 |
| Device Manufacturer Date | 1999-08-01 |
| Date Added to Maude | 2012-05-17 |
| 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 | STEVE MEADE |
| Manufacturer Street | 6025 NICOLLE STREET 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 | CONFORM BINDER SUBMALAR, MEDIUM |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2012-05-10 |
| Model Number | NA |
| Catalog Number | CBSM-M |
| Lot Number | 606390 |
| ID Number | NA |
| Device Expiration Date | 2004-08-01 |
| 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 | 2012-05-10 |