MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for CONTOURFLEX(TM) CALF IMPLANTE TEXTURED (CARLSEN STYLE) N/A CCB7-T0C#L manufactured by Implantech Associates, Inc..
[127539748]
Method: testing was performed on actual devices associated with this report. Implantech reviewed production/manufacturing records. Results: evaluation found no device problem. (device complied with specifications. ) conclusion: no problem was detected.
Patient Sequence No: 1, Text Type: N, H10
[127539749]
(this is the same patient and same event being reported in medwatch report # 2028924-2018-00007. ) complainant reported that the dimensions of the implants did not match those that we have listed. The initial report indicated that the patient had been put under anesthesia, and they had to wake her up without doing the surgery due to their concerns regarding the dimensions. Subsequent follow-up revealed that the patient had other surgical procedures performed on that date, and that the intended surgery to implant the "subject" devices was not the sole reason why the patient was placed under anesthesia. No subsequent intervention has been reported. Though there is no clear information that the reported event necessarily constitutes a serious injury, implantech has elected to report this event in the abundance of caution. (the event date will be considered to be (b)(6) 2018, the date of the surgery in which "subject" devices were not implanted due to the concerns reported above. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00008 |
| MDR Report Key | 8081377 |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-18 |
| Device Manufacturer Date | 2018-07-25 |
| Date Added to Maude | 2018-11-16 |
| 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 | 0 |
| Brand Name | CONTOURFLEX(TM) CALF IMPLANTE TEXTURED (CARLSEN STYLE) |
| Generic Name | CONTOURED CARVING BLOCK |
| Product Code | MIB |
| Date Received | 2018-11-16 |
| Returned To Mfg | 2018-11-02 |
| Model Number | N/A |
| Catalog Number | CCB7-T0C#L |
| Lot Number | 878746 |
| 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. Other | 2018-11-16 |