MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-15 for VARADY PHLEBECTOMY EXTRACTOR,6-3/4,SM HOOK/SPATULA 10310 manufactured by Integra York, Pa Inc..
[97859928]
Investigation completed on (b)(6) 2018. There was one varady phlebectomy extractor/hook manufactured on (b)(6) 2014 which was returned used/processed and showing wear. The complaint report of a broken tip has been confirmed but the root cause of the damage has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[97859929]
It was reported by a nurse administrator that on (b)(6) 2017, the hook of 10310 varady phlebectomy extractor broke off during an unspecified procedure and was stuck inside the extracted vein. There was no patient injury nor any revisions or medical interventions done. Additional information was already requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00004 |
| MDR Report Key | 7189073 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-15 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2017-12-21 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2018-01-15 |
| 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 | MS. KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARADY PHLEBECTOMY EXTRACTOR,6-3/4,SM HOOK/SPATULA |
| Generic Name | JARIT |
| Product Code | GAI |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2018-01-02 |
| Catalog Number | 10310 |
| Lot Number | 100088-1411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-15 |