MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-17 for CAMINO HAND DRILL 030 manufactured by Integra Neurosciences.
[17801993]
A report was rec'd by the manufacturer that the device did not function properly. The reported malfunction caused a delay in surgery to perform a ventriculostomy. The pt had suffered a closed head injury on an unknown date, necessitating the ventriculostomy. A new device was obtained, and the surgical procedure was continued. No further info has been made available regarding the condition of the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023988-2000-00003 |
| MDR Report Key | 300836 |
| Report Source | 05,06 |
| Date Received | 2000-10-17 |
| Date of Report | 2000-10-12 |
| Date of Event | 2000-06-30 |
| Date Mfgr Received | 2000-09-18 |
| Date Added to Maude | 2000-10-20 |
| 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 | NANCY MATHEWSON |
| Manufacturer Street | 5955 PACIFIC CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584551115 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAMINO HAND DRILL |
| Generic Name | HAND DRILL |
| Product Code | HBG |
| Date Received | 2000-10-17 |
| Returned To Mfg | 2000-10-16 |
| Model Number | 030 |
| Catalog Number | 030 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 291183 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | 5955 PACIFIC CENTER BLVD. SAN DIEGO CA 92121 US |
| Baseline Brand Name | CAMINO HAND DRILL |
| Baseline Generic Name | HAND DRILL |
| Baseline Model No | 030 |
| Baseline Catalog No | 030 |
| Baseline Device Family | CAMINO DISPOSABLES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K862160 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2000-10-17 |