MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-07-26 for TENDERFOOT DEVICES 50/PKM TF501 manufactured by International Technidyne Corporation.
[1593977]
Customer reports that while the nurse was administering a heel stick on the patient with tenderlett device, device split open and the lance came out the side instead of the bottom of the device. No injury reported to nurse or patient.
Patient Sequence No: 1, Text Type: D, B5
[8680517]
(b)(4). Product complaint is currently being investigated by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2010-00010 |
| MDR Report Key | 1774703 |
| Report Source | 05,06 |
| Date Received | 2010-07-26 |
| Date of Report | 2010-07-26 |
| Date of Event | 2010-06-18 |
| Date Mfgr Received | 2010-07-14 |
| Date Added to Maude | 2011-02-18 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE PICCIANO |
| Manufacturer Street | 23 NEVSKY ST. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 7325485700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENDERFOOT DEVICES 50/PKM |
| Generic Name | NEWBORN HEEL INCISION DEVICE |
| Product Code | JCA |
| Date Received | 2010-07-26 |
| Model Number | TF501 |
| Catalog Number | TF501 |
| Lot Number | NA |
| 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 | 2010-07-26 |