MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-24 for POWERFLEX (TM) PECTORAL IMPLANT N/A ACPI-4R manufactured by Implantech Associates, Inc..
[70780362]
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed sterilization records, manufacturing records, and product labeling. Results: no failure was detected. Conclusion: the possibility of serous fluid accumulations (seromas) is a know, inherent risk associated with implant surgery.
Patient Sequence No: 1, Text Type: N, H10
[70780363]
Complainant reported that after explant and immediate replacement of prior right side pectoral implant (refer to mdr# 2028924-2017-00001), that the patient has had continuing problems with recurring seromas on the right side. Approximately 6 weeks after replacement device was implanted, the pectoral implants were explanted bilaterally due to the recurring seromas on the right side. Implantech has elected to report this event although the patient symptomology that led to the reportable intervention was present in the patient prior to the device being implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2017-00003 |
| MDR Report Key | 6431805 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-02-24 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2017-03-24 |
| 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 | MR. CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERFLEX (TM) PECTORAL IMPLANT |
| Generic Name | PECTORAL IMPLANT |
| Product Code | MIC |
| Date Received | 2017-03-24 |
| Model Number | N/A |
| Catalog Number | ACPI-4R |
| Lot Number | 869068 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-24 |