MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-11-13 for HAND DRILL STERILE INS030 manufactured by Integra Pain Mgmt.
[5045917]
The device does not drill straight; twisted. The customer used another hand drill available. Additional info was requested and on (b)(6) 2014 the following was received. There was no pt injury or death alleged. The event lead to an increase in surgery time of 15 minutes (high intracranial pressure during 15 minutes in more for the pt). The issue was discovered when implementing. The surgery was reported as micro dialysis. There was no possibility to use the hand drill / twist rotation. There was no consequence to the pt because material was checked before using. No other info was provided.
Patient Sequence No: 1, Text Type: D, B5
[12519352]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722447-2014-00014 |
| MDR Report Key | 4254487 |
| Report Source | 01,05 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-10-20 |
| Date Mfgr Received | 2014-10-20 |
| Date Added to Maude | 2014-11-26 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAND DRILL STERILE |
| Generic Name | NA |
| Product Code | HBG |
| Date Received | 2014-11-13 |
| Catalog Number | INS030 |
| Lot Number | W1406070 |
| Device Expiration Date | 2017-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA PAIN MGMT |
| Manufacturer Address | SALT LAKE CITY UT 84104 US 84104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-13 |