MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2008-06-12 for PERIPHERAL NERVE STIMULATOR NS252AUU manufactured by Fisher & Paykel Healthcare, Ltd..
[872342]
A healthcare facility in another country, reported that a pt got a minor burn while the peripheral nerve stimulator was being used.
Patient Sequence No: 1, Text Type: D, B5
[8067482]
An investigation will be carried out once we receive the complaint device. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2008-00365 |
| MDR Report Key | 1059824 |
| Report Source | 01,05,06,08 |
| Date Received | 2008-06-12 |
| Date of Report | 2008-05-20 |
| Date Mfgr Received | 2008-05-20 |
| Date Added to Maude | 2009-06-03 |
| 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 | GORDON RICHMAN |
| Manufacturer Street | 15365 BARRANCA PKWY |
| Manufacturer City | IRVINE CA 926182216 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182216 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE |
| Manufacturer City | EAST TAMAKI, AUCKLAND |
| Manufacturer Country | NZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | BXN |
| Date Received | 2008-06-12 |
| Model Number | NS252AUU |
| Catalog Number | NS252AUU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Address | AUCKLAND NZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-12 |