MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-01 for TENDERFOOT DEVICE 1000/CS TF1000I manufactured by International Technidyne Corp..
[2352891]
Itc sales rep reports that the demo kit blade on her tenderfoot device did not fully retract. No report of injury. No adverse event(s) reported.
Patient Sequence No: 1, Text Type: D, B5
[9486665]
(b)(4). Result - no other complaints received for this lot. A search of complaints for the past 1 year indicated no other cases of failure to retract. Conclusion - device expected to return to itc for eval. Eval of retain samples for same lot performed according to specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2011-00028 |
| MDR Report Key | 2337025 |
| Report Source | 05 |
| Date Received | 2011-11-01 |
| Date of Report | 2011-10-04 |
| Date Mfgr Received | 2011-10-04 |
| Device Manufacturer Date | 2010-10-20 |
| Date Added to Maude | 2012-07-11 |
| 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 | LAWRENCE PICCIANO |
| Manufacturer Street | 20 CORPORATE PALCE SOUTH |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer Street | 23 NEVSKY ST. |
| 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 DEVICE 1000/CS |
| Product Code | JCA |
| Date Received | 2011-11-01 |
| Model Number | TF1000I |
| Catalog Number | TF1000I |
| Lot Number | BH007 |
| Device Expiration Date | 2014-06-01 |
| 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 | 2011-11-01 |