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 2014-06-16 for DEKNATEL DEK BL MF 0 TC-43/HR 26 2N 833-124 manufactured by Teleflex.
[4622582]
The event is reported as: complaint alleged issue: it was reported that during sacrospinous fixation (ssf) "after cutting the suture by the doctor, the nurse noticed that suture was split. " pt has not complications.
Patient Sequence No: 1, Text Type: D, B5
[12061159]
The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No rejection report were originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled adn inspected according to our specs. No corrective actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect. At this time due to the lack of defective product is not possible to determine the source of the defect reported. Customer complaint can not be confirmed due the lack of product sample to perform a proper investigation and determine the root cause. However, the mfr will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00227 |
| MDR Report Key | 3963498 |
| Report Source | 01,05,06,08 |
| Date Received | 2014-06-16 |
| Date of Report | 2014-05-26 |
| Date of Event | 2014-05-15 |
| Date Mfgr Received | 2014-05-26 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-08-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BRWON, REGULATORY AFFAIRS |
| Manufacturer Street | 4024 STIRRUP CREEK DR STE #720 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9196314124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEKNATEL DEK BL MF 0 TC-43/HR 26 2N |
| Generic Name | SUTURE |
| Product Code | GAO |
| Date Received | 2014-06-16 |
| Catalog Number | 833-124 |
| Lot Number | 02C1300770 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-16 |