MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2012-03-01 for DEKNATEL BL MF 0 TC-43 2N 48? 833-123 manufactured by Teleflex Medical.
[20957698]
The event is reported as: complaint alleges: the suture was being placed at the pelvic floor near the sacrospinous ligament when the needle detached. The break was at the needle. During a sacrospinous fixation, the bullet came off the suture and the bullet was lost in the body. No pt complications reported.
Patient Sequence No: 1, Text Type: D, B5
[21212382]
A device history record (dhr) was previously reviewed under another similar complaint. The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. Dhr show that the product was assembled and inspected according to specifications. No conclusion can be established at this time due to the lack of defective sample and that the dhr does not show any issues or discrepancies which could potentially relate to this complaint. If the sample becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2012-00094 |
| MDR Report Key | 2481206 |
| Report Source | 01,06,07,08 |
| Date Received | 2012-03-01 |
| Date of Report | 2012-02-07 |
| Date of Event | 2012-02-07 |
| Date Mfgr Received | 2012-02-15 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2012-04-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEKNATEL BL MF 0 TC-43 2N 48? |
| Generic Name | SUTURE |
| Product Code | MFJ |
| Date Received | 2012-03-01 |
| Catalog Number | 833-123 |
| Lot Number | 02F1003349 |
| Operator | OTHER |
| 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 | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-01 |