MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-27 for DEKNATEL EK BL MF 0 TC-43/HR 26 N 833-124 manufactured by Teleflex Medical.
[5926579]
Alleged issue: during the procedure, the surgeon placed the suture. When the surgeon removed the capio slim device, the bullet head of the suture was missing. It was confirmed that the bullet remained inside the patient. A second capio slim device and second suture was used to complete the case. No patient complications. Patient current condition reported, as fine.
Patient Sequence No: 1, Text Type: D, B5
[13280978]
Qn#: (b)(4). No sample is available for the mfr to evaluate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00154 |
| MDR Report Key | 4801691 |
| Report Source | 05,06 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-15 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-05-15 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-06-23 |
| 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 | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| 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 | DEKNATEL EK BL MF 0 TC-43/HR 26 N |
| Generic Name | SUTURE NEEDLE |
| Product Code | GAO |
| Date Received | 2015-05-27 |
| Catalog Number | 833-124 |
| Lot Number | 74E1400235 |
| ID Number | 1900038557 |
| Device Expiration Date | 2019-05-31 |
| 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 MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-27 |