MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2015-06-04 for DEK BL MF 0 TC-43 2N 48 833-123 manufactured by .
[5840965]
Complaint alleges that the bullet came off the suture while in use with the capio device. The bullet (small fragment tip) was located on an x-ray but they were unable to retrieve it. Patient's condition was reported as unk.
Patient Sequence No: 1, Text Type: D, B5
[13503982]
Qn # (b)(4). A device history record (dhr) review did not show issues related to complaint. No sample is available for the manufacturer to evaluate. However, the manufacturer will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00144 |
| MDR Report Key | 4820852 |
| Report Source | 01,05,06,08 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-05-05 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-05-05 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-07-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DORIS STURGIS, RA ASSOCIATE |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334953 |
| 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 | DEK BL MF 0 TC-43 2N 48 |
| Generic Name | SUTURE |
| Product Code | MFJ |
| Date Received | 2015-06-04 |
| Catalog Number | 833-123 |
| Lot Number | 74E1402023 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-04 |