MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-19 for HTR-PEKK PK620905 manufactured by Oxford Performance Materials.
[114538226]
The sales rep reported that there was an infection approximately 1 week post-op. The patient was treated with antibiotics and the infection has resolved. There is no revision planned. No sterilization records are available. There is no known history of infection at the facility. This is report 2 of 2, as two separate devices were implanted at the same time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009582362-2018-00005 |
| MDR Report Key | 7704867 |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-06-28 |
| Device Manufacturer Date | 2018-06-05 |
| Date Added to Maude | 2018-07-19 |
| 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 | PO BOX 585 30 SOUTH SATELLITE ROAD |
| Manufacturer City | SOUTH WINDSOR CT 06074 |
| Manufacturer Country | US |
| Manufacturer Postal | 06074 |
| Manufacturer Phone | 8606569450 |
| Manufacturer G1 | OXFORD PERFORMANCE MATERIALS |
| Manufacturer Street | PO BOX 585 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 | 2018-07-19 |
| Model Number | PK620905 |
| Lot Number | 202446-001 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OXFORD PERFORMANCE MATERIALS |
| Manufacturer Address | PO BOX 585 30 SOUTH SATELLITE ROAD SOUTH WINDSOR CT 06074 US 06074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-19 |