MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for CAPIO 833-114 manufactured by Teleflex Medical.
[60776129]
Patient Sequence No: 1, Text Type: N, H10
[60776130]
During surgery, the surgeons present were using a capio suture device inside of a patient when the bullet broke off into the patient. Due to the small size of the piece that broke off (approximately 3 mm), the surgeons were unable to recover the device. An x-ray was ordered in the pacu, but the piece was not found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6124224 |
| MDR Report Key | 6124224 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-10-19 |
| Report Date | 2016-10-27 |
| Date Reported to FDA | 2016-10-27 |
| Date Reported to Mfgr | 2016-10-27 |
| Date Added to Maude | 2016-11-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO |
| Generic Name | SUTURE, NEEDLE |
| Product Code | GAO |
| Date Received | 2016-11-23 |
| Catalog Number | 833-114 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD. MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-23 |