MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-22 for CONTOURFLEX TEARDROP GLUTEAL IMPLANT CCB6-3 manufactured by Implantech Associates Inc..
[21878301]
Complainant reported that pt presented with seroma, pain, and swelling on the right side approximately two months after bilateral implantation. Pt was aspirated on several occasions and prescribed levaquin. The right side device was explanted due to infection approximately 11 weeks post implantation. Cultures from the device were negative, however, cultures from the pt found "few 2+ acid fast bacilli". Subsequent testing identified the organism as mycobacterium gordonae. The complainant did not feel the infection was device-related, and intended to reimplant using the same device. Implantech offered complainant a no charge replacement, and complainant reimplanted the right side device approximately 5 months after initial implantation using the no charge replacement.
Patient Sequence No: 1, Text Type: D, B5
[21919973]
Method: reviewed device history records, sterilization records, environmental monitoring records, and device labeling. Results: device history record 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 (b)(4) products. ) product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2014-00001 |
| MDR Report Key | 3603285 |
| Report Source | 05 |
| Date Received | 2014-01-22 |
| Date of Report | 2014-01-22 |
| Date of Event | 2013-10-28 |
| Date Mfgr Received | 2013-12-31 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-02-04 |
| 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. |
| 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 | CONTOURFLEX TEARDROP GLUTEAL IMPLANT |
| Generic Name | GLUTEAL IMPLANT |
| Product Code | MIB |
| Date Received | 2014-01-22 |
| Model Number | NA |
| Catalog Number | CCB6-3 |
| Lot Number | 849926 |
| ID Number | NA |
| Device Expiration Date | 2018-05-01 |
| 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 | 2014-01-22 |