MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-07-10 for EXCEL 36KHZ STRAIGHT HANDPIECE EACH1 C2602 manufactured by Integra Lifesciences(ireland).
| Report Number | 3006697299-2019-00075 |
| MDR Report Key | 8775691 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-07-10 |
| Date of Report | 2019-06-13 |
| Date Mfgr Received | 2019-07-11 |
| Device Manufacturer Date | 2018-10-01 |
| Date Added to Maude | 2019-07-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES(IRELAND) |
| Manufacturer Street | IDA BUSINESS&TECHNOLOGY PARK |
| Manufacturer City | SRAGH, TULLAMORE, CO.OFFALY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXCEL 36KHZ STRAIGHT HANDPIECE EACH1 |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2019-07-10 |
| Catalog Number | C2602 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES(IRELAND) |
| Manufacturer Address | IDA BUSINESS&TECHNOLOGY PARK IDA BUSINESS&TECHNOLOGY PARK SRAGH, TULLAMORE, CO.OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-10 |