MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2017-12-26 for DEVON 31145827 manufactured by Covidien.
[95836268]
Submit date: 12/26/2017. An investigation is currently under way; upon completion the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[95836269]
The customer states that the team has found our surgical markers to be bleeding and leaving a jagged line for the incision placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2017-05260 |
| MDR Report Key | 7145617 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-12-26 |
| Date of Report | 2018-03-21 |
| Date Mfgr Received | 2017-12-03 |
| Date Added to Maude | 2017-12-26 |
| 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 | CALLE 9 SUR NO. 1113 CUIDAD |
| Manufacturer City | TIJUANA,NA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVON |
| Generic Name | MARKER, SKIN |
| Product Code | FZZ |
| Date Received | 2017-12-26 |
| Model Number | 31145827 |
| Catalog Number | 31145827 |
| Lot Number | 1715777464 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 1113 CUIDAD TIJUANA,NA 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-26 |