MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-04 for DEKNATEL TEV TRI BR 2-0 KT-3 30"X9 PFM G79-114C9K manufactured by Teleflex Medical.
[20324244]
Complaint alleges: it was reported that during an aortic valve replacement procedure, while tying the stitches down, they broke. The surgeon replaced the sutures and finished the case. There was no harm to the patient and no medical intervention was required. The patient is in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[20530681]
Device history record (dhr) shows that the product was assembled and inspected according to manufacturer's specifications. Device sample received by manufacturer, but investigation is still underway at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00383 |
| MDR Report Key | 4240081 |
| Report Source | 05,06 |
| Date Received | 2014-11-04 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-09-05 |
| Date Mfgr Received | 2014-10-10 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-11-17 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEKNATEL TEV TRI BR 2-0 KT-3 30"X9 PFM |
| Generic Name | NEEDLE |
| Product Code | OVN |
| Date Received | 2014-11-04 |
| Returned To Mfg | 2014-10-23 |
| Catalog Number | G79-114C9K |
| Lot Number | 02A1401018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RTP NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-04 |