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 2017-01-06 for 1053NPSM KCAT 3/PK 100 PK/CASE 31424719 manufactured by Covidien.
[64055986]
Submit date: 01/06/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[64055987]
It was reported to covidien on (b)(6) 2016 that a customer experienced an adverse event with electrodes. The customer states that the clear plastic backing of the electrodes inadvertently drop to the floor. When the backing is on the floor, no one can see them causing people to slip. One nurse broke a bone in her foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681860-2017-00009 |
| MDR Report Key | 6228940 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-14 |
| Date Mfgr Received | 2016-12-14 |
| Date Added to Maude | 2017-01-06 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 215 HERBERT STREET |
| Manufacturer City | GANANOQUE |
| Manufacturer Country | CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1053NPSM KCAT 3/PK 100 PK/CASE |
| Generic Name | ELECTRODES |
| Product Code | GXY |
| Date Received | 2017-01-06 |
| Model Number | 31424719 |
| Catalog Number | 31424719 |
| Lot Number | 624615X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 215 HERBERT STREET GANANOQUE CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-06 |