MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-07-07 for CAPIO SUTURING DEVICE manufactured by Teleflex.
[4705919]
Alleged issue: the bullet came off the suture. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[11953306]
A device history report review (dhr) or root cause could not be conducted since the lot number was not provided and no sample returned. The manufacturer will continue to monitor and trend related complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00242 |
| MDR Report Key | 3997990 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-07 |
| Date of Report | 2014-06-25 |
| Date of Event | 2014-06-01 |
| Date Mfgr Received | 2014-06-25 |
| Date Added to Maude | 2014-08-20 |
| 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, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194332672 |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINO #1316, RANCHO EL DESCANSO |
| Manufacturer City | TECTATE |
| Manufacturer Country | MX |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO SUTURING DEVICE |
| Generic Name | SUTURE |
| Product Code | MFJ |
| Date Received | 2014-07-07 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | NUEVO LAREDO, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-07 |