MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-22 for TERINO MALAR SHELL-LARGE, 4MM TMS-L4 manufactured by .
[2642304]
Physician reported that shortly after implantation with malar implants, the pt presented with persistent edema. Twenty-six days post-op, the devices were explanted and a culture was taken. Culture resulted in mycobacterium chelonae/mycobacterium abscessus group. Pt was seeing a specialist for this type of infection. Additional info has been requested from the reporting physician.
Patient Sequence No: 1, Text Type: D, B5
[9927963]
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 871 products).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2012-00003 |
| MDR Report Key | 2589899 |
| Report Source | 05 |
| Date Received | 2012-05-22 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-03-28 |
| Date Mfgr Received | 2012-04-23 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2012-05-30 |
| 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, 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 | TERINO MALAR SHELL-LARGE, 4MM |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2012-05-22 |
| Model Number | NA |
| Catalog Number | TMS-L4 |
| Lot Number | 820759 |
| ID Number | NA |
| Device Expiration Date | 2011-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-22 |