MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-08 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[27768547]
Additional information: cuff: catalog #: 72401982; expiration date: 4/22/2019; serial #: (b)(4); manufacture date: 4/2014. Pump: catalog #: 72402287; expiration date: 11/20/2015; serial #: (b)(4), manufacture date: 11/2014. Balloon: catalog #: 72402106; expiration date: 4/17/2018; serial #: (b)(4), manufacture date: 5/2013. The explanted action bowel sphincter was visually inspected and functionally tested. The pump performed within specifications. The balloon pressure tested at 99. 7 cmh2o. It was originally rated at 101-110 cmh2o. There was a leak in the cuff that was the result of a sharp instrument.
Patient Sequence No: 1, Text Type: N, H10
[27768548]
It was reported the patient had his action bowel sphincter removed due to erosion and infection. No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2015-00422 |
| MDR Report Key | 5136596 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-14 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-09-14 |
| Date Added to Maude | 2015-10-08 |
| 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 | 2015-10-08 |
| Returned To Mfg | 2015-09-24 |
| 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 | 2015-10-08 |