MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-24 for TELEFLEX CAPIO SUTURE 833-213 manufactured by Teleflex.
[5071211]
The bulleted needle popped off the suture and was lost in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038894 |
| MDR Report Key | 4217309 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-10-24 |
| Date of Event | 2014-10-23 |
| Date Added to Maude | 2014-11-03 |
| 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 | TELEFLEX CAPIO SUTURE |
| Generic Name | CAPIO SUTURE |
| Product Code | MFJ |
| Date Received | 2014-10-24 |
| Catalog Number | 833-213 |
| Lot Number | 02A1401752 |
| Device Expiration Date | 2019-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RTP NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-24 |