MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-10-03 for HIBBS CHISEL 9-1/2 ST 3/8 27-420 manufactured by Integra York - Miltex.
[2278787]
Customer service rep at the distributor's office, was examining the device. When she put the protective cover back on the tip of the chisel she was injured. Tip went through the cover, which she believes was already slit. She describes her injury as "non life threatening, similar to a paper cut". There was potential for greater harm.
Patient Sequence No: 1, Text Type: D, B5
[9304164]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00067 |
| MDR Report Key | 2281796 |
| Report Source | 08 |
| Date Received | 2011-10-03 |
| Date of Report | 2011-10-03 |
| Date Mfgr Received | 2011-09-22 |
| Date Added to Maude | 2012-07-06 |
| 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 | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIBBS CHISEL 9-1/2 ST 3/8 |
| Generic Name | M10 - ORTHOPEDIC |
| Product Code | EML |
| Date Received | 2011-10-03 |
| Catalog Number | 27-420 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK - MILTEX |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-03 |