MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-26 for TENDERFOOT HEEL INCISION DEVICE TF50I manufactured by International Technidyne Corp..
[4755727]
Distributor reports end user was injured during use of the tenderfoot. The tenderfoot device fell apart in the users hand after the device was used on the patient. The nurse sustained a puncture to the left pointer finger. The hospital's needle stick injury procedure was followed, including reporting and blood specimen testing. At this time, no subsequent adverse events associated with this event have been reported to itc. This event occurred outside of the united states.
Patient Sequence No: 1, Text Type: D, B5
[12148906]
This mdr submitted (b)(4) 2014, references itc complaint case (b)(4). Patient code: the end user reported experienced a needle stick/puncture. Device code: no information device has been returned to manufacturer an is currently undergoing evaluation. Method code: no testing methods performed. Device has been returned to manufacturer and is currently undergoing evaluation. Result code: results pending completion of evaluation. Conclusion code: conclusion not yet available-evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2014-00004 |
| MDR Report Key | 3966516 |
| Report Source | 01,08 |
| Date Received | 2014-06-26 |
| Date of Report | 2014-05-27 |
| Date of Event | 2014-05-19 |
| Date Mfgr Received | 2014-05-27 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-08-06 |
| 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 |
| Manufacturer G1 | INTERNATIONAL TECHNIDYNE CORP. |
| 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 HEEL INCISION DEVICE |
| Generic Name | DEVICE, BLEEDING TIME |
| Product Code | JCA |
| Date Received | 2014-06-26 |
| Returned To Mfg | 2014-06-10 |
| Model Number | TF50I |
| Catalog Number | TF50I |
| Lot Number | BC309M |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-06-26 |