MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-06 for MEDPOR IMPLANT 89020 manufactured by Porex Surgical.
[484266]
The doctor reported that he placed two medpor cranial implants and the pt developed symptomatic hematomas. The doctor stated that the pt had pulmonary emboli and was on anticoagulants pre-op and post-op and this may have contributed to the development of the hematomas. The doctor reported that the implant was removed due to the symptomatic hematomas.
Patient Sequence No: 1, Text Type: D, B5
[7779688]
The device history records for this lot were checked from processing to finished goods product and is within specification. Sterility testing was performed as required and all test passed. There is no evidence of device failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2006-00011 |
| MDR Report Key | 732833 |
| Report Source | 05 |
| Date Received | 2006-07-06 |
| Date of Report | 2006-06-29 |
| Date Mfgr Received | 2006-06-14 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2006-07-12 |
| 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 Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| 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 IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JAZ |
| Date Received | 2006-07-06 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | B007E50H/B009E50H |
| ID Number | NA |
| Device Expiration Date | 2016-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 721138 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Baseline Brand Name | MEDPOR INPLANT |
| Baseline Generic Name | FACILA RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 89020 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-07-06 |