MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2011-10-25 for OEM UNKNOWN CAPIO SUTURE manufactured by Teleflex Medical.
[2225075]
The event is reported as: complaint alleged: suture fell out of the device and was found on the floor after surgery. Surgery continued with an alternative device. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9383257]
No sample or lot# was returned for investigation. Eval: method: no sample was returned. A complaint history review was performed. Results: the complaint history review for 1 year cannot be associated with other complaints with the same issue due to part number is unk. No dhr review could be performed due to lack of lot#. Conclusions: no root cause could be established due to lack of sample. No corrective actions taken. If sample becomes available, complaint will be opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00442 |
| MDR Report Key | 2324412 |
| Report Source | 06,08 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-10-12 |
| Date of Event | 2011-09-20 |
| Date Mfgr Received | 2011-10-17 |
| Date Added to Maude | 2012-04-26 |
| 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 | OEM UNKNOWN CAPIO SUTURE |
| Generic Name | SUTURE |
| Product Code | MFJ |
| Date Received | 2011-10-25 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2011-10-25 |