MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-08-14 for SHUNT TUNNELER 990010 manufactured by Integra Neurosciences Implants Sa.
[2795336]
A shunt tunneler was being used during an unspecified procedure. The cap of the single use tunneler had fallen off into the pt. The unit had to be removed. The report described that the pt was injured, however the injury was not described. The age and the gender of the pt is unk. The event lead to an increase of surgery time of 15 mins. Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10226807]
The device involved in the reported incident is not expected to be rec'd for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612007-2012-00027 |
| MDR Report Key | 2702671 |
| Report Source | 01,06 |
| Date Received | 2012-08-14 |
| Date of Report | 2012-08-14 |
| Date of Event | 2012-07-23 |
| Date Mfgr Received | 2012-07-24 |
| Date Added to Maude | 2012-08-17 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHUNT TUNNELER |
| Generic Name | VALVE ACCESSORIES |
| Product Code | GYK |
| Date Received | 2012-08-14 |
| Catalog Number | 990010 |
| Lot Number | 170524 |
| Device Expiration Date | 2015-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES IMPLANTS SA |
| Manufacturer Address | SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-14 |