MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-23 for MANOSCAN RFG-1286 manufactured by Given Imaging Los Angeles Llc.
[103698606]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103698607]
According to the reporter, the catheter got stuck in the nose that needed assistance from the physician to remove the catheter. Upon removal it was discovered that the tpe has a tear in it and blood has gotten into the device. The patient experienced moderate bleeding when the device was removed from the nose. The catheter got stuck upon extubation, while the physician attempted to remove with lubricant and irrigation. After a few attempts, the device was reintroduced into the stomach and was able to be removed, with slight difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2018-00003 |
| MDR Report Key | 7366267 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-23 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-03-23 |
| 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 | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Street | 5860 UPLANDER WAY |
| Manufacturer City | CULVER CITY CA 90230 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90230 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANOSCAN |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-03-23 |
| Model Number | RFG-1286 |
| Catalog Number | RFG-1286 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Address | 5860 UPLANDER WAY CULVER CITY CA 90230 US 90230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-23 |