MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-12-08 for UNKNOWN OEM CAPIO DEVICE manufactured by Teleflex Medical.
[20733849]
The event is reported as: during the anterior and posterior repair procedure, the account reported that the physician was throwing the suture, and the needle tip got stuck in the capio device. The problem occurred inside the pt. The case was completed with another of the same device with no harm to the pt. No reported pt consequences. Needle remained in the capio device. .
Patient Sequence No: 1, Text Type: D, B5
[20905767]
No sample was received for investigation. No lot# provided. Eval results: no investigation could be conducted due to lack of sample and lot#. Conclusions: no corrective actions can be established since the info related to the part number and lot number is unavailable to perform an investigation; therefore, the issue cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00520 |
| MDR Report Key | 2405830 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-08 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-11-01 |
| Date Mfgr Received | 2011-12-06 |
| Date Added to Maude | 2012-04-27 |
| 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 | PO 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 | UNKNOWN OEM CAPIO DEVICE |
| Generic Name | CAPIO DEVICE |
| Product Code | MFJ |
| Date Received | 2011-12-08 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2011-12-08 |