MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-14 for SEPRAMESH IP manufactured by Genzyme Biosurgery (sepramesh).
| Report Number | 1221601-2019-00012 |
| MDR Report Key | 8700292 |
| Date Received | 2019-06-14 |
| Date of Report | 2019-06-13 |
| Date Added to Maude | 2019-06-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. HEATHER SCHIAPPACASSE |
| Manufacturer Street | 55 CORPORATE DRIVE, MS 55B-220 A |
| Manufacturer City | BRIDGEWATER 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer G1 | GENZYME BIOSURGERY (SEPRAMESH) |
| Manufacturer Street | 76 NEW YORK AVENUE |
| Manufacturer City | FRAMINGHAM 01701 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01701 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEPRAMESH IP |
| Generic Name | MCN |
| Product Code | MCN |
| Date Received | 2019-06-14 |
| Lot Number | 06NP104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME BIOSURGERY (SEPRAMESH) |
| Manufacturer Address | 76 NEW YORK AVENUE FRAMINGHAM 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-06-14 |