MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-05-01 for LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION UNK manufactured by Pluromed Inc.
[17128641]
Occlusion in lower part of leg distal from the anastomosis [vascular occlusion]. Case description: spontaneous report was received on (b)(4) 2013 from a physician via a sales rep regarding a pt, initials unk. The pt's medical history was not provided. On an unspecified date, legoo (endovascular occlusion gel) was used during an unspecified surgery for vascular occlusion. The lot number for legoo was not provided. It was reported that after the legoo injection, there was an occlusion in the lower part of the leg distal from the anastomosis. The company assessed the event of occlusion in the lower part of the leg distal from the anastomosis as medically significant. The outcome and intensity for the event of occlusion in the lower part of the leg distal from the anastomosis was not provided. Concomitant medications were not provided. The reporting physician did not provide the relationship of legoo with the event.
Patient Sequence No: 1, Text Type: D, B5
[17323688]
Mfr's comment: the benefit-risk relationship of the legoo is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008867907-2013-00002 |
| MDR Report Key | 3113588 |
| Report Source | 05,07 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-04-25 |
| Date Mfgr Received | 2013-04-25 |
| Date Added to Maude | 2013-05-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL ST |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | PLUROMED INC |
| Manufacturer Street | 175 NEW BOSTON ST SUITE F |
| Manufacturer City | WOBURN MA 01801000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01801 0000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION |
| Generic Name | ENDOVASCULAR OCCLUSION GEL |
| Product Code | OBC |
| Date Received | 2013-05-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLUROMED INC |
| Manufacturer Address | WOBURN MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-01 |