MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for MEDI-TRACE CADENCE 22550A manufactured by Covidien.
[115772501]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[115772502]
The customer reported the gel is detached from the electrode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2018-00014 |
| MDR Report Key | 7736844 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2017-06-13 |
| Date Added to Maude | 2018-07-31 |
| 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 | 2 LUDLOW PARK DR |
| Manufacturer City | CHICOPEE MA 010221318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 010221318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDI-TRACE CADENCE |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | MLN |
| Date Received | 2018-07-31 |
| Model Number | 22550A |
| Catalog Number | 22550A |
| Lot Number | 718024X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARK DR CHICOPEE MA 010221318 US 010221318 |
| Brand Name | MEDI-TRACE CADENCE |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | DRO |
| Date Received | 2018-07-31 |
| Model Number | 22550A |
| Catalog Number | 22550A |
| Lot Number | 718024X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARK DR CHICOPEE MA 010221318 US 010221318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |