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 2018-02-20 for MANOSCAN 1286 manufactured by Given Imaging Los Angeles Llc.
[100670941]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100670942]
According to the reporter, the device was difficult to remove from the patient. Initially the catheter was inserted without difficulty. However upon removal, there was a large amount of resistance met, and the patient stated that it was painful when they are attempting to remove the catheter. The charge nurse was notified and attempted to remove the catheter but was unsuccessful. The physician was called to remove the catheter but is also unsuccessful. Then another nurse requested to remove the catheter but the patient refused. The physician then requested some forceps to attempt to grab the catheter from the back of the throat and nudge the catheter through the nasal passage way to remove without damage to the catheter, but was unsuccessful. At this point it was decided to pull the catheter part way through the mouth and cut for removal. The catheter was removed without complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2018-00002 |
| MDR Report Key | 7283820 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-20 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-02-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| 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 | 2018-02-20 |
| Model Number | 1286 |
| Catalog Number | 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 | 2018-02-20 |