MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-22 for MANOSCAN RFG-3890 manufactured by Given Imaging Los Angeles Llc.
[95746652]
Patient Sequence No: 1, Text Type: N, H10
[95746653]
According to the reporter, customer called to report that a probe got stuck in patient's body. Patient felt discomfort and a little amount of bleeding. Patient reported feeling better the next day. Customer emailed study showing failure on probe. Customer emailed the study and after review, tech support confirmed that every sixth sensors failed. The device will be replaced and sent back for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2017-05009 |
| MDR Report Key | 7142107 |
| Report Source | CONSUMER |
| Date Received | 2017-12-22 |
| Date of Report | 2018-02-08 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2017-12-22 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| 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 | 2017-12-22 |
| Returned To Mfg | 2017-12-05 |
| Model Number | RFG-3890 |
| Catalog Number | RFG-3890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-12-22 |