MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-12-27 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[1778947]
It was reported the device was popping and hissing during use. There were no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
[8942742]
We are in the process of evaluating this device. When our investigation is complete, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2010-00015 |
| MDR Report Key | 1961590 |
| Report Source | 05,06,07 |
| Date Received | 2010-12-27 |
| Date of Report | 2010-12-01 |
| Date Mfgr Received | 2010-12-01 |
| Date Added to Maude | 2012-01-23 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | SETH KERSTEN |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 240 SANTA ANA COURT |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAWAND LP |
| Generic Name | ULTRAWAND LP |
| Product Code | NTB |
| Date Received | 2010-12-27 |
| Model Number | 12400 |
| Catalog Number | 12400 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-27 |