MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-29 for MEDPOR 89020 manufactured by Porex Surgical.
[1665504]
The doctor stated that the patient received medpor right cranial and medpor left cranial implants on (b)(6) 2010. The doctor stated that prior to placing the medpor implants he removed a previously placed non medpor implant because the patient had a bacterial infection. The doctor stated that he believed that the infection had cleared before placing the medpor implants. The doctor reported that around mid (b)(6), he noticed drainage around the implant site and removed the implant on (b)(6) 2010. The doctor stated that the patient is currently being treated with antibiotics and antifungal.
Patient Sequence No: 1, Text Type: D, B5
[8897538]
Lot number information:item no. Lot no. Expiration date manufacture date89020 mci-365-10 f001g81h 07-13-2020 07-13-2010;89020 mci-366-10 f004g81h 07-13-2020 07-13-2010. A review of the device history records for the lot numbers listed was conducted and all process and test parameters were within the medpor implant specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00036 |
| MDR Report Key | 1886372 |
| Report Source | 05 |
| Date Received | 2010-10-29 |
| Date of Report | 2010-10-27 |
| Date of Event | 2010-10-05 |
| Date Mfgr Received | 2010-10-18 |
| Device Manufacturer Date | 2010-07-13 |
| Date Added to Maude | 2010-11-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 6784791610 |
| Manufacturer G1 | POREX SURGICAL |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 1017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR |
| Generic Name | MEDPOR CUSTOMIZED SURGICAL IMPLANTS |
| Product Code | JOF |
| Date Received | 2010-10-29 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | F001G81H, F004G81H |
| ID Number | 510K#083621 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265101 US 30265 1017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-29 |