MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-01 for UNKNOWN manufactured by Implantech Associates Inc..
[24953852]
(reviewed labeling for implantech chin implants. Implantech has long warned of possibility of the formation or contracture of fibrous tissue capsule which may result in pain). Results: anticipated or known.
Patient Sequence No: 1, Text Type: N, H10
[24953853]
Complainant reported that approximately 15 years post-implantation with a chin implant, pt developed mild intermittent chin pain. Due to these symptoms and pt desire for more anterior chin projection, pt had the chin implant explanted and replaced with another device. A hard osseous capsule was found around the implant. The replacement implant was trimmed in order to fit within existing capsule, which was not broken up and removed. The complainant acknowledged not being able to definitively identify the original device as an implantech device, however implantech has elected to report this event in good faith so the fda can be made aware of an event associated with chin implants, regardless of the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2015-00004 |
| MDR Report Key | 5052701 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-01 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-10 |
| Date Mfgr Received | 2015-08-12 |
| Date Added to Maude | 2015-09-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE ST., 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 | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | FWP |
| Date Received | 2015-09-01 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2015-09-01 |