MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-31 for TENDERFOOT 50PK DEVICES TF501 manufactured by International Technidyne Corporation.
[1951772]
Healthcare professional reports user injury using tenderfoot 50pk device. Customer reported that a nurse was using the device to incise a pt. She put the device down on the counter expecting the blade to have retracted. Cleaning up afterwards, she picked up the device and cut her right thumb. The cut was treated using standard needlestick protocol for the site. The cut was washed out and wiped with alcohol. No adverse event (s) reported.
Patient Sequence No: 1, Text Type: D, B5
[9109623]
(b)(4). Method: no product returned. Result: customer complaint could not be confirmed. Conclusion: device not returned. No conclusion can be drawn. Batch record was reviewed and no anomalies were noted. No other complaints were received for this lot. A search of complaints for the past 2 years indicates no other cases of failure to retract. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2011-00007 |
| MDR Report Key | 2068117 |
| Report Source | 05 |
| Date Received | 2011-03-31 |
| Date of Report | 2011-03-15 |
| Date of Event | 2011-03-13 |
| Date Mfgr Received | 2011-03-15 |
| Device Manufacturer Date | 2010-10-20 |
| Date Added to Maude | 2012-02-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE PICCIANO |
| Manufacturer Street | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer Street | 8 OSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENDERFOOT 50PK DEVICES |
| Product Code | JCA |
| Date Received | 2011-03-31 |
| Model Number | TF501 |
| Catalog Number | TF501 |
| Lot Number | BN036 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORPORATION |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-31 |