MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-29 for TENDERFOOT HEEL INCISION DEVICE TF1000I manufactured by International Technidyne Corp..
[21081996]
Healthcare professional reported that the tenderfoot device came apart prior to use and was not used. No adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
[21438430]
This mdr submitted 10/28/2014 refers to itc complaint case (b)(4). Retrospective analysis of complaint records where the tenderfoot identified this case for reportability. No ncmrs were identified for the device. No related complaint trends identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2014-00007 |
| MDR Report Key | 4239929 |
| Report Source | 05,06 |
| Date Received | 2014-10-29 |
| Date of Report | 2013-12-17 |
| Date of Event | 2013-12-17 |
| Date Mfgr Received | 2013-12-17 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-11-14 |
| 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 | ELEANOR FOX |
| 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 HEEL INCISION DEVICE |
| Product Code | JCA |
| Date Received | 2014-10-29 |
| Model Number | TF1000I |
| Catalog Number | TF1000I |
| Lot Number | BH336M |
| Device Expiration Date | 2017-06-01 |
| 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 CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-29 |