MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-11-25 for AMS ACTICON NEOSPHINCTER SEE H10 manufactured by American Medical Systems (mn).
[5004710]
It was reported the patient had an acticon device revision due to infection and fluid loss. It was reported that, "all components were filled with sludge and debris. " no additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[12575218]
The acticon device was visually inspected. There was a leak in the cuff pillow that was the result of wear at a fold. The pump and balloon were not functionally tested due to the confirmed cuff leak. Pump, catalog #: 720046-01, serial #: (b)(4), expiration date: 04/10/2011, manufacture date: 04/2008; balloon, catalog #: 72402106, serial #: (b)(4), expiration date: 06/04/2012, manufacture date: 06/2007; cuff, catalog #: 72401960, serial #: (b)(4), expiration date: 01/22/2013, manufacture date: 01/2008;
Patient Sequence No: 1, Text Type: N, H10
[29942739]
Correcting: was reported as: pump: catalog #: 720046-01, serial #: (b)(4), expiration date: 04/10/2011, manufacture date: 04/2008. Corrected to: pump: catalog #: 72402287, serial #: (b)(4), expiration date: 02/22/2013, manufacture date: 02/2008.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2014-00533 |
| MDR Report Key | 4276195 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-11-25 |
| Date of Report | 2014-11-03 |
| Date of Event | 2014-10-31 |
| Date Mfgr Received | 2015-10-28 |
| Date Added to Maude | 2014-11-25 |
| 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 | 3 |
| Manufacturer Contact | MRS. SHARON ZURN |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306000 |
| Manufacturer G1 | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS ACTICON NEOSPHINCTER |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | MIP |
| Date Received | 2014-11-25 |
| Returned To Mfg | 2014-11-03 |
| Catalog Number | SEE H10 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-11-25 |