MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2011-10-31 for PILLING LARGE VESSEL APPROX. 15MM BLADES 065195 manufactured by Teleflex.
[21980612]
No sample is available for the mfr to evaluate. A f/u report will be sent when investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[22094141]
The event is reported as: complaint alleged: "the vessel doesn't fix well. " issue was reported prior to use on a pt, during insp/functionality testing. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-2011-00106 |
| MDR Report Key | 2336893 |
| Report Source | 01,06,07,08 |
| Date Received | 2011-10-31 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-09-28 |
| Date Mfgr Received | 2011-10-18 |
| Date Added to Maude | 2012-01-10 |
| 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 | 3 |
| Health Professional | 3 |
| 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 |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING LARGE VESSEL APPROX. 15MM BLADES |
| Generic Name | VESSEL APPROXIMATOR |
| Product Code | HRQ |
| Date Received | 2011-10-31 |
| Catalog Number | 065195 |
| Lot Number | JO |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-31 |