MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for HTR-PEKK PK620905 manufactured by Oxford Performance Materials.
[139954506]
The sales rep received information from the physician that she plans to remove the implant, as it was infected again. Upon follow up, it was reported that the patient had had an infection approximately one-week post op. At that time, the patient was treated with antibiotics and the infection was thought to have been resolved. The sales rep was unable to confim whether this is a different type of infection or when it was identified. This report is 1 of 2 as two seperate devices were implanated at the same time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009582362-2019-00003 |
| MDR Report Key | 8452615 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-06-05 |
| Date Added to Maude | 2019-03-26 |
| 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 | BETH PASHKO |
| Manufacturer Street | 30 SOUTH SATELLITE ROAD |
| Manufacturer City | SOUTH WINDSOR CT 06074 |
| Manufacturer Country | US |
| Manufacturer Postal | 06074 |
| Manufacturer Phone | 8606569450 |
| Manufacturer G1 | OXFORD PERFORMACE MATERIALS |
| Manufacturer Street | 30 SOUTH SATELLITE ROAD |
| Manufacturer City | SOUTH WINDSOR CT 06074 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HTR-PEKK |
| Generic Name | FACIAL IMPLANT |
| Product Code | KKY |
| Date Received | 2019-03-26 |
| Model Number | PK620905 |
| Lot Number | 202446-001 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OXFORD PERFORMANCE MATERIALS |
| Manufacturer Address | PO BOX 585 30 SOUH SATELLITE ROAD SOUTH WINDSOR CT 06074 US 06074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-26 |