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 2010-04-07 for IRE SINGLE ELECTRODE PROBE 20400101 manufactured by Angiodynamics.
[18904660]
Lot history record review: the lot number was not provided. A ship history showed that the following lots had been shipped in the last 6 months: 081106 and 080911. The complaint info was forwarded to (b)(4). (b)(4) reviewed the possible lot history records and found no variances related to this event were observed. Review of returned sample: the complaint sample was not returned for eval. Conclusion: this type of complaint is still currently under investigation. F/u report to follow. Frequency has increased, but the severity of this event is not greater than usual.
Patient Sequence No: 1, Text Type: N, H10
[19057777]
Pt was treated by dr (b)(6) medical center, (b)(6) 2010. Immediately prior to irreversible electroporation treatment, pt had been voiding freely without assistance. Pt does have a history of post-surgical urinary retention after abdominal peritoneal resection. He reported to dr (b)(6) nurse that he had to do self-straight-catheterization for a period of about 2 months after apr. He eventually regained voiding independence. During the ire procedure, pt did not have an indwelling foley catheter. After procedure, he developed urinary retention. Seventy two hours post ire, pt is performing intermittent straight catheterization to drain bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2010-00014 |
| MDR Report Key | 1657896 |
| Report Source | 05,06,07 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-03-31 |
| Date of Event | 2010-03-09 |
| Date Mfgr Received | 2010-03-15 |
| Date Added to Maude | 2011-02-04 |
| 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 | 0 |
| Manufacturer Contact | MARGARET MCGUIRE |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRE SINGLE ELECTRODE PROBE |
| Generic Name | IRE SINGLE ELECTRODE PROBE |
| Product Code | OHJ |
| Date Received | 2010-04-07 |
| Catalog Number | 20400101 |
| Lot Number | NOT REPORTED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-07 |