MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-04-24 for CUSA EXCEL 36KHZ TUBING SET C3601 manufactured by Integra Lifesciences Ireland Limited.
[4461730]
C3601 cusa excel 36khz tubing set had a hair found in the sealed package. The hair was discovered during incoming inspection by the distributor. There was no pt contact.
Patient Sequence No: 1, Text Type: D, B5
[11974274]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2014-00025 |
| MDR Report Key | 3866474 |
| Report Source | 01,08 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-04-01 |
| Date Mfgr Received | 2014-04-01 |
| Date Added to Maude | 2014-06-25 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE RD |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL 36KHZ TUBING SET |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2014-04-24 |
| Catalog Number | C3601 |
| Lot Number | 1132943 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES IRELAND LIMITED |
| Manufacturer Address | SRAGH TULLAMORE, CO OFFALY 0000 EI 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-24 |