MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-02-03 for CAPIO SUTURES manufactured by Teleflex Medical.
[5497955]
Alleged issue: it was reported that the tapercut needle broke from suture and remained behind in the patient. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[12912109]
(b)(4). The device sample has not been returned to the manufacturer for investigation at the time of this report. The dhr could not be conducted because the lot number was not provided. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00054 |
| MDR Report Key | 4488352 |
| Report Source | 01,05,07 |
| Date Received | 2015-02-03 |
| Date of Report | 2015-01-09 |
| Date of Event | 2014-08-25 |
| Date Mfgr Received | 2015-01-09 |
| Date Added to Maude | 2015-03-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EFFIE JEFFERSON, REG AFFAIRS |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO SUTURES |
| Generic Name | SUTURE |
| Product Code | MFJ |
| Date Received | 2015-02-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-03 |