MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-18 for DEVON 31145777 manufactured by Covidien.
[86603155]
Submit date: 09/18/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[86603156]
The customer reports that the open marker cap and the tip of the pen was damaged. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[113437172]
There were no samples submitted with this complaint. The complaint shall be reopened if a sample is received. The reported condition by the customer could not be confirmed without a sample to evaluate. 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 condition 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. A production notification was issued to all personnel to ensure that they are aware on the condition reported by the customer. The current process is running according to product specifications meeting quality acceptance criteria. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2017-05174 |
| MDR Report Key | 6874836 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-18 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-09-18 |
| 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 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 | 2017-09-18 |
| Model Number | 31145777 |
| Catalog Number | 31145777 |
| Lot Number | 7100106564 |
| 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 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-18 |