MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2011-06-01 for CAPIO SUTURE UNK manufactured by Teleflex Medical.
[17185577]
Eval conclusions: no conclusion can be drawn. No conclusion can be established due to the lack of info regarding the product code, lot number and lack of reported defective sample. No eval will be performed.
Patient Sequence No: 1, Text Type: N, H10
[17195716]
The event is reported as: the needle of the capio suture detached inside the pt. The physician attempted to locate the needle, but was unsuccessful. The needle was not retrieved from the pt. It is reported that there is no complications and that the pt is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2011-00216 |
| MDR Report Key | 2145629 |
| Report Source | 05,06,08 |
| Date Received | 2011-06-01 |
| Date of Report | 2011-05-19 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2011-05-19 |
| Date Added to Maude | 2012-03-23 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO SUTURE |
| Generic Name | CAPIO SUTURE |
| Product Code | MFJ |
| Date Received | 2011-06-01 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-06-01 |