MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-27 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[5423504]
It was reported the patient had his action removed due to infection, diarrhea, exposure, and anal pain. The patient had experienced diarrhea and anal pain; anterior exposure and positive blood cultures were discovered during examination. The action was removed due to infection from exposure. Abdominal adhesions were also discovered. No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[12778364]
Additional information: cuff: catalog #: 72401982, expiration date: 4/02/2018, serial #: (b)(4), manufacture date: 4/2013. Pump: catalog #: 72402287, expiration date: 10/09/2014, serial #: (b)(4), manufacture date: 10/2013. Balloon: catalog #: 72402106, expiration date: 04/02/2018, serial #: (b)(4), manufacture date: 04/2013. The explanted action device was visually inspected and functionally tested. The pump performed within specifications. There was a leak in the cuff that was the result of a sharp instrument which probably occurred during removal. The balloon tested at 94. 1 cmh2o. It is rated at 101-110 cmh2o.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2015-00044 |
| MDR Report Key | 4454400 |
| Report Source | 05 |
| Date Received | 2015-01-27 |
| Date of Report | 2015-01-16 |
| Date of Event | 2014-06-27 |
| Date Mfgr Received | 2015-01-16 |
| Date Added to Maude | 2015-01-27 |
| 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 | 2015-01-27 |
| Returned To Mfg | 2015-01-16 |
| 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 | 2015-01-27 |