MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-25 for MEDPOR IMPLANT 83007 manufactured by Porex Surgical.
[707660]
A representative from a doctor's office reported that a patient received left and right medpor midface contour implants and a medpor nasal dorsum implant in 2007. The representative stated that approximately two weeks after the surgery, the patient reported to the doctor that she had serious hives over her entire body and swelling in the face. The doctor reported that the patient has an unusual idiopathic urticaria that could have been a result of an inability to metabolize an anesthetic agent. The doctor stated that the patient went to an allergist who stated that the patient had not had an allergic reaction. The doctor reported that the area around the left medpor midface implant developed an infection and was treated with abx. The doctor stated that the infection did not resolve and left medpor midface implant was removed.
Patient Sequence No: 1, Text Type: D, B5
[8013930]
The device history records for the lot were reviewed and all processes and test criteria have been verified as complying with the medpor implants specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00018 |
| MDR Report Key | 933694 |
| Report Source | 05 |
| Date Received | 2007-10-25 |
| Date of Report | 2007-10-25 |
| Date of Event | 2007-10-15 |
| Date Mfgr Received | 2007-10-15 |
| Device Manufacturer Date | 2006-08-24 |
| Date Added to Maude | 2007-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | LZK |
| Date Received | 2007-10-25 |
| Model Number | NA |
| Catalog Number | 83007 |
| Lot Number | B044H14 |
| ID Number | NA |
| Device Expiration Date | 2016-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 908747 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-25 |