MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-01-15 for KERLIX 6715 manufactured by Covidien.
[97430169]
Submit date: 01/15/2018. An investigation is currently underway. 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
[97430170]
The customer reports that when the package was opened, they observed a foreign object within the package. On (b)(6) 2018, the manufacturing facility performed an evaluation on the returned sample, and upon visual inspection, it was found that the radiopaque strip was missing. Based on this information, this is a reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2018-00008 |
| MDR Report Key | 7192095 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-01-15 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2018-01-08 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2018-01-15 |
| 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 | 1647 PERKINS RD |
| Manufacturer City | AUGUSTA GA 30913 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30913 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERLIX |
| Generic Name | GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2018-01-02 |
| Model Number | 6715 |
| Catalog Number | 6715 |
| Lot Number | 17K106062 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1647 PERKINS RD AUGUSTA GA 30913 US 30913 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-15 |