MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-09-01 for DEK BL MF 0 FX45 2N 48" BARD DEK200 manufactured by Teleflex Medical.
[24716329]
(b)(4). The device history review could not be conducted since the lot number was not provided. The device sample has not been returned for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[24716330]
Alleged event: the bullet was not caught by the device and the suture broke. The bullet remained in the patient and was unable to be removed. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00263 |
| MDR Report Key | 5046027 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-09-01 |
| Date of Report | 2015-08-04 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-08-04 |
| Date Added to Maude | 2015-09-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 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 FX45 2N 48" BARD |
| Generic Name | SUTURE |
| Product Code | OVN |
| Date Received | 2015-09-01 |
| Catalog Number | DEK200 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-01 |