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 2017-12-22 for BIS 186-1046 manufactured by Mallinckrodt Medical.
[95819129]
Patient Sequence No: 1, Text Type: N, H10
[95819130]
Medtronic received a report stating that a 186-1046 unit's cable emitted a burned/scorched odor. There was no patient harm reported with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020889-2017-05203 |
| MDR Report Key | 7143252 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-22 |
| Date of Report | 2018-04-19 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2012-01-04 |
| 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 | AVI MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MALLINCKRODT MEDICAL |
| Manufacturer Street | CORNAMADDY |
| Manufacturer City | ATHLONE 3810 |
| Manufacturer Postal Code | 3810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIS |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | OLW |
| Date Received | 2017-12-22 |
| Returned To Mfg | 2017-12-12 |
| Model Number | 186-1046 |
| Catalog Number | 186-1046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT MEDICAL |
| Manufacturer Address | CORNAMADDY ATHLONE 3810 3810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-22 |