MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-31 for DEVON 31160545 manufactured by Covidien.
[81396093]
Submit date: 7/31/17. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[81396094]
The customer states that these markers were found to be leaking.
Patient Sequence No: 1, Text Type: D, B5
[130081198]
There were no samples submitted with this complaint. The complaint shall be reopened if a sample is received. The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer. The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. Since a sample was not evaluated a root cause could not be identified and no corrective actions were deemed necessary at this moment. The current process is running according to product specifications meeting quality acceptance criteria. A production notification was issued to all personnel to ensure that they are aware on the condition reported by the customer. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2017-05130 |
| MDR Report Key | 6753904 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-31 |
| Date of Report | 2018-02-08 |
| Date Mfgr Received | 2017-07-01 |
| Date Added to Maude | 2017-07-31 |
| 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 | CALLE 9 SUR NO. 125 CUIDAD |
| Manufacturer City | TIJUANA,NA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| 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 | 2017-07-31 |
| Model Number | 31160545 |
| Catalog Number | 31160545 |
| Lot Number | 1714776064 |
| 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. 125 CUIDAD TIJUANA,NA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-31 |