MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-11 for UNKNOWN ENDOFLIP CATHETER manufactured by Crospon Ltd.
[138493618]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138493619]
According to the reporter, the patient had a pseudoachalasia and perforation after dilation. The patient died and during autopsy, they found the patient to have a metastatic breast cancer that caused the stricture in the esophagus. The patient also had a malignant pleural effusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2019-00003 |
| MDR Report Key | 8410243 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-11 |
| Date of Report | 2019-06-04 |
| Date Mfgr Received | 2019-05-13 |
| Date Added to Maude | 2019-03-11 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | CROSPON LTD |
| Manufacturer Street | GALWAY BUSINESS PARK, DANGAN |
| Manufacturer City | GALWAY,FL H91P2DK |
| Manufacturer Postal Code | H91P2DK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ENDOFLIP CATHETER |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2019-03-11 |
| Model Number | UNKNOWN ENDOFLIP CATHETER |
| Catalog Number | UNKNOWN ENDOFLIP CATHETER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSPON LTD |
| Manufacturer Address | GALWAY BUSINESS PARK, DANGAN GALWAY,FL H91P2DK H91P2DK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-03-11 |