MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-21 for MEDPOR IMPLANT 89020 manufactured by Porex Surgical.
[1580209]
The doctor reported to the porex surgical sales representative that the pt received a medpor right cranial implant on (b) (6), 2010. The doctor stated that the pt was having an acute inflammatory reaction and the medpor right cranial implant was explanted on (b) (6), 2010. The doctor stated that it was a (b) (6) infection that caused the pt to degrade rapidly within 36 hours after implantation. The doctor reported that the pt is on antibiotics and doing fine.
Patient Sequence No: 1, Text Type: D, B5
[8566508]
Following a review of the device history record for lot number 89020-mci-096-10 f012c28h, it was determined that all processes and test criteria are within the medpor implant finished product specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00010 |
| MDR Report Key | 1667033 |
| Report Source | 05 |
| Date Received | 2010-04-21 |
| Date of Report | 2010-04-20 |
| Date of Event | 2010-03-23 |
| Date Mfgr Received | 2010-03-25 |
| Device Manufacturer Date | 2010-03-04 |
| Date Added to Maude | 2010-04-28 |
| 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 RD. |
| 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 | 2010-04-21 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | MCI-09610 F012C28H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-21 |