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 2012-04-30 for OEM UNKNOWN CAPIO SUTURE manufactured by Teleflex Medical.
[14927408]
The event is reported as: complaint alleges: during gripping, the needle remained stuck. No patient injury reported. Patient current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[15274247]
No sample is available for investigation. The device history report (dhr) could not be conducted since the lot number was not provided. Complaint cannot be confirmed. No corrective action can be established at this moment since the defective sample and batch number are not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2012-00165 |
| MDR Report Key | 2561676 |
| Report Source | 01,06,07,08 |
| Date Received | 2012-04-30 |
| Date of Report | 2012-04-09 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-04-16 |
| Date Added to Maude | 2012-05-17 |
| 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 | ELAINE BURKLE, RN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OEM UNKNOWN CAPIO SUTURE |
| Generic Name | CAPIO SUTURE |
| Product Code | MFJ |
| Date Received | 2012-04-30 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| 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 | 2012-04-30 |