MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for POWERFLEX(TM) PECTORAL IMPLANT TEXTURED (NOVACK STYLE 2) N/A BNPI2-T-1L manufactured by Implantech Associates, Inc..
[182510632]
Investigation involved physical evaluation of the device associated with report. Evaluation confirms that device labeled as left side was actually a right side device. Though a review of the device history record for the reported device found no errors or omissions that might account for the reported event, implantech has determined that this event is linked to a prior complaint investigation (refer to report # 2028924-2019-00004) in which a right side or bnpi2-t-1r was reported to actually be the left side or bnpi2-t-1l device. The complainant in the current report was contacted as part of prior complaint investigation and reported that device had already been implanted, and the doctor had no issues or comments associated with the device. At the time, the scope of event was limited to the 1 device. Based on the evidence from both complaint investigations, the probable cause of the reported event is a product mix-up (1:1 switch) between two product lots. The scope of this issue is now limited to the two devices associated with report 2028924-2019-00004 and this report 2028924-2020-00001 respectively. The outcome was incorrect labeling as evidence suggests a left side device was labeled as a right side device. Implantech attributes cause to a manufacturing error (i. E product mix-up), with a deficiency in quality control processes as a secondary cause. No further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[182510633]
The complainant reported that patient received pectoral implants bilaterally, and subsequently complained of dissatisfaction with result on the left side approximately 7 months post-operatively. Approximately 10 months post-operatively, the patient had left side device explanted and replaced due to displacement/patient dissatisfaction. Upon explant, the complainant reported that the device removed from the left side was actually a right side device. Both sides were found to be right sides.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2020-00001 |
| MDR Report Key | 9700544 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2018-08-04 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERFLEX(TM) PECTORAL IMPLANT TEXTURED (NOVACK STYLE 2) |
| Generic Name | CONTOURED CARVING BLOCK IMPLANT |
| Product Code | MIC |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-02-06 |
| Model Number | N/A |
| Catalog Number | BNPI2-T-1L |
| Lot Number | 877112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-12 |