MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-11 for DEK BL MF 0 TC-43/HR 26 2N 36" 833-124 manufactured by Teleflex Medical.
[31200074]
(b)(4). The device history record of batch number 74e1402012 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. The device sample was reportedly discarded. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[31200075]
Alleged event: two metal darts at the end of the sutures broke off inside the patient and they were not retrieved. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00341 |
| MDR Report Key | 5217223 |
| Date Received | 2015-11-11 |
| Date of Report | 2015-11-06 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-11-06 |
| Device Manufacturer Date | 2014-05-20 |
| Date Added to Maude | 2015-11-11 |
| 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 | 0 |
| Brand Name | DEK BL MF 0 TC-43/HR 26 2N 36" |
| Product Code | OVN |
| Date Received | 2015-11-11 |
| Catalog Number | 833-124 |
| Lot Number | 74E1402012 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-11-11 |