MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-07-14 for CRANIAL ACCESS KIT BIT W/5.31MM, PKG EAD * 030 manufactured by Clinical Neuro Systems.
[291192]
The customer claims that the hand drills from 2 ins hith kits broke while in use. The customer is only returning one out of the two for evaluation. The other kit was disposed of by the customer there was pt contact but no injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028223-2003-00008 |
| MDR Report Key | 472228 |
| Report Source | 05,06 |
| Date Received | 2003-07-14 |
| Date of Report | 2003-07-14 |
| Date Mfgr Received | 2003-06-19 |
| Date Added to Maude | 2003-07-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JENNA KARABAS |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362236 |
| Manufacturer G1 | CLINICAL NEURO SYSTEMS |
| Manufacturer Street | 309 COMMERCE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIAL ACCESS KIT BIT W/5.31MM, PKG EAD |
| Generic Name | CRANIAL ACCESS |
| Product Code | HBG |
| Date Received | 2003-07-14 |
| Model Number | * |
| Catalog Number | 030 |
| Lot Number | B03051 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 461079 |
| Manufacturer | CLINICAL NEURO SYSTEMS |
| Manufacturer Address | 309 COMMERCE DR. EXTON PA 19341 US |
| Baseline Brand Name | CRINIAL ACCESS SINGLE STERILE HAND DRILL |
| Baseline Generic Name | CRINIAL ACCESS |
| Baseline Model No | * |
| Baseline Catalog No | 030 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-14 |