MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-01-23 for INNERVATOR NS252 NA manufactured by Fisher & Paykel Healthcare, Ltd..
[589713]
Fisher & paykel healthcare ltd nerve stimulator (ns252) and electrode pad used during a surgical procedure. Following the 4 to 5 hr procedure (nephrectomy) the pad was removed from the male pt's face. The outside of the pad had a 'burn' mark, and the pt's skin showed a slight red mark which disappeared after 2 days.
Patient Sequence No: 1, Text Type: D, B5
[7819014]
Complaint from hospital was received by phone call to our company office on 22 dec 06. Follow-up contact by us office with hospital was attempted tuesday dec 26, left message on answerphone. Return voice mail received tues. Dec 26 indicating ns252 had been sent to a 3rd party for further investigation. Follow-up contact attempted again by our company on monday jan 08 2007-return voicemail from the reporter, indicated that further follow-up on the incident should be conducted with biomedical engineering. Company office contacted from the reporter, it was identified that a cauterizer was in use and active when the ns252 was applied. A list of questions was sent to the hospital on or around the 17 jan 07. As of 22 jan 07 no reply received. We are awaiting further response from the hospital. Note: ns252 is reusable device, electrode pads are single use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2007-00009 |
| MDR Report Key | 824229 |
| Report Source | 06,07 |
| Date Received | 2007-01-23 |
| Date of Report | 2007-01-23 |
| Date of Event | 2006-12-20 |
| Date Mfgr Received | 2006-12-22 |
| Date Added to Maude | 2007-03-09 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PETRY |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND |
| Manufacturer Country | NZ |
| Manufacturer Phone | 5740100 |
| Manufacturer G1 | * |
| Manufacturer Street | PO BOX 14348, PANMURE |
| Manufacturer City | AUCKLAND |
| Manufacturer Country | NZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNERVATOR |
| Generic Name | NERVE STIMULATOR |
| Product Code | BXN |
| Date Received | 2007-01-23 |
| Model Number | NS252 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 051123-911 (PAD) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 811629 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Address | * AUCKLAND NZ |
| Baseline Brand Name | INNERVATOR NS252 |
| Baseline Generic Name | PERIPHERAL NERVE STIMULATOR |
| Baseline Model No | NS252 |
| Baseline Catalog No | NS252 |
| Baseline ID | * |
| Baseline Device Family | CONSTANT CURRENT PERIPHERAL NERVE STIMULATORS |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882438 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-23 |