MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-23 for S-SPECIAL-COMBINED-M4/TT4/H4.3 SEE BRAND NAME manufactured by Implantech Associates, Inc..
[2004447]
The physician reported that pt indicated that swelling occurred shortly after surgery. On (b)(6) 2011, swelling was aspirated, and the fluid submitted for culture. Ultimately, mycobacterium chelonae was identified. Pt has been treated with oral cipro and vioxin. The swelling responds to this intervention and pt has not reflared yet after last time. Surgery to explant the device is not planned, but it may be needed if infection does not resolve.
Patient Sequence No: 1, Text Type: D, B5
[9021864]
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 125 products. ) product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2011-00001 |
| MDR Report Key | 2112395 |
| Report Source | 05 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-05-23 |
| Date of Event | 2011-02-01 |
| Date Mfgr Received | 2011-04-25 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2011-06-09 |
| 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 | STEVE 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 | S-SPECIAL-COMBINED-M4/TT4/H4.3 |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2011-05-23 |
| Model Number | NA |
| Catalog Number | SEE BRAND NAME |
| Lot Number | 838042 |
| ID Number | NA |
| Device Expiration Date | 2015-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2011-05-23 |