MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-23 for AMS ACTICON NEOSPHINCTER 72401956 manufactured by American Medical Systems (mn).
[5315347]
It was reported that the patient's acticon neosphincter was removed because of fluid loss and "return to fecal incontinence". No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[12764664]
Additional components: pump catalog number: 72402287, serial number: (b)(4), manufacture date: 07/25/2006, expiration date: 07/20/2011. Balloon catalog number: 72402106, serial number: (b)(4), manufacture date: 06/30/2006, expiration date: 07/20/2011. Evaluation summary: the acticon device was visually inspected. There was a leak in the cuff pillow that was the result of fatigue and wear at a fold. The pump and balloon were not functionally tested due to the cuff leak. There was a leak in the cuff tube that was the result of tool damage which probably occurred during removal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2015-00031 |
| MDR Report Key | 4444540 |
| Report Source | 05 |
| Date Received | 2015-01-23 |
| Date of Report | 2015-01-12 |
| Date of Event | 2015-01-06 |
| Date Mfgr Received | 2015-01-12 |
| Device Manufacturer Date | 2004-08-02 |
| Date Added to Maude | 2015-01-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 2015-01-23 |
| Returned To Mfg | 2015-01-12 |
| Catalog Number | 72401956 |
| Device Expiration Date | 2009-07-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2015-01-23 |