MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-18 for ENDOROTOR ER 10-01-OP manufactured by Interscope, Inc..
| Report Number | 3011697028-2019-00001 |
| MDR Report Key | 9337038 |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-10-09 |
| Device Manufacturer Date | 2019-01-03 |
| Date Added to Maude | 2019-11-18 |
| 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 | 3 |
| Manufacturer Contact | JEFFERY RYAN |
| Manufacturer Street | 100 MAIN ST SUITE 108 |
| Manufacturer City | WHITINSVILLE MA 01588 |
| Manufacturer Country | US |
| Manufacturer Postal | 01588 |
| Manufacturer Phone | 8004614289 |
| Manufacturer G1 | INTERSCOPE, INC. |
| Manufacturer Street | 100 MAIN ST SUITE 108 |
| Manufacturer City | WHITINSVILLE MA 01588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOROTOR |
| Generic Name | ENDOSCOPIC MORCELLATOR |
| Product Code | PTE |
| Date Received | 2019-11-18 |
| Model Number | ER 10-01-OP |
| Catalog Number | ER 10-01-OP |
| Lot Number | 525108C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSCOPE, INC. |
| Manufacturer Address | 100 MAIN ST SUITE 108 WHITINSVILLE MA 01588 US 01588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-18 |