MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-01-27 for MEDPOR IMPLANTS 9509 manufactured by Porex Surgical.
[393446]
Event was reported concerning implantation of the malar implant in 3/03 resulting in a follow-up visit in 11/03 where the pt presented dehiscence in the incision. Treatment with antibiotics yielded no success. Implants were removed five weeks later. Porex surgical is unaware of why there was a delay in reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00004 |
| MDR Report Key | 568953 |
| Report Source | 08 |
| Date Received | 2005-01-27 |
| Date of Report | 2004-12-03 |
| Date of Event | 2003-12-18 |
| Date Mfgr Received | 2004-10-14 |
| Device Manufacturer Date | 2002-07-01 |
| Date Added to Maude | 2005-02-01 |
| 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 | 0 |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 6784791610 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANTS |
| Generic Name | FACIAL AUGMENTATION AND RECONSTRUCTION |
| Product Code | LZK |
| Date Received | 2005-01-27 |
| Model Number | 9509 |
| Catalog Number | 9509 |
| Lot Number | 041100702 |
| ID Number | * |
| Device Expiration Date | 2012-07-01 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 558782 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA 302651017 US |
| Baseline Brand Name | MEDPOR IMPLANTS |
| Baseline Generic Name | FACIAL AUGMENTATION AND RECONSTRUCTION |
| Baseline Model No | 9509 |
| Baseline Catalog No | 9509 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-27 |