MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-01 for AUTO ENDO5 ML 543965 manufactured by Teleflex Medical.
[17618191]
The event is reported as: complaint alleges: clip was not loading properly and would fall out of the applier. No pt injury reported. Pt current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[17716072]
No sample is available for the mfr to evaluate. A device history record (dhr) review did not show any issues related to this complaint. Complaint cannot be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it. Complaint cannot be confirmed since the sample was not available for investigation, however, we will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2013-00514 |
| MDR Report Key | 3532508 |
| Report Source | 05,06 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-10-23 |
| Date Mfgr Received | 2013-10-23 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-01-31 |
| 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 | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINO # 1316, RANCHO EL DESCANSO |
| Manufacturer City | TECATE, B.C. C.P.214 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | C.P. 2147 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO ENDO5 ML |
| Generic Name | CLIP APPLIER |
| Product Code | HCI |
| Date Received | 2013-11-01 |
| Catalog Number | 543965 |
| Lot Number | 01B1300125 |
| 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 | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-01 |