MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-15 for MEDPOR IMPLANT 81124 manufactured by Porex Surgical, Inc..
[419014]
The doctor had placed a medpor coated tear drain into a patient and had to replace the tear drain due to patient discomfort from an exposed portion of the medpor portion of the tear drain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00023 |
| MDR Report Key | 621499 |
| Report Source | 05 |
| Date Received | 2005-07-15 |
| Date of Report | 2005-07-15 |
| Date of Event | 2004-09-29 |
| Date Mfgr Received | 2004-09-29 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2005-07-19 |
| 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 AUGMENTATION AND RECONSTRUCTION. |
| Product Code | JAZ |
| Date Received | 2005-07-15 |
| Model Number | NA |
| Catalog Number | 81124 |
| Lot Number | 0031721103H |
| ID Number | * |
| Device Expiration Date | 2013-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 611146 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 15 DART RD. NEWNAN GA 30265 US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL AUGMENTATION AND RECONSTRUCTION. |
| Baseline Model No | NA |
| Baseline Catalog No | 81124 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-15 |