MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-09-10 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[4895131]
It was reported by the patient that she is unhappy with the placement of her acticon balloon because of "scar tissue/fistula" in the area causing "pain/discomfort". No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[12301282]
Cuff: catalog #: 72401980, expiration date: 1/15/2015, serial #: (b)(4), manufacture date: 1/2010, implant date: (b)(6) 2013. Pump: implant date: 2008, balloon: catalog #: 72402105, expiration date: 07/12/2017, serial #: (b)(4), manufacture date: 07/2012, implant date: (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2014-00396 |
| MDR Report Key | 4079545 |
| Report Source | 04 |
| Date Received | 2014-09-10 |
| Date of Report | 2014-08-18 |
| Date Mfgr Received | 2014-08-18 |
| Date Added to Maude | 2014-09-10 |
| 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 | 0 |
| 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 | 2014-09-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-09-10 |