MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-17 for COVIDIEN 173016 manufactured by Covidien.
[19416597]
Using the covidien endostitch with a 2-0 surgidac suture to place mesh within the pt's abdomen. When pulling device out the suture stayed within the tissue and mesh inside the pt. Surgeon did not retrieve stating to explore and remove suture would cause more harm to pt then leaving the needle alone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028309 |
| MDR Report Key | 2887588 |
| Date Received | 2012-12-17 |
| Date of Report | 2012-12-17 |
| Date of Event | 2012-12-13 |
| Date Added to Maude | 2012-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COVIDIEN |
| Generic Name | ENDOSTITCH |
| Product Code | MFJ |
| Date Received | 2012-12-17 |
| Model Number | 173016 |
| Lot Number | N2J0589X |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-17 |