MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,foreign,health professi report with the FDA on 2015-07-16 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[6434840]
It was reported the patient had her acticon balloon and pump removed and replaced due to incontinence. It was indicated that there was blood found in the balloon, there was not fluid loss, and "they are not defected". No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[14202510]
Cuff: catalog #: 72401964, expiration date: 08/13/2017, serial #: (b)(4), manufacture date: 06/2011. Balloon: catalog #: 72402104, expiration date: 3/25/2018, serial #: (b)(4), manufacture date: 04/2013. Pump: catalog #: 72402287, expiration date: 04/25/2015, serial #: (b)(4), manufacture date: 05/2014.
Patient Sequence No: 1, Text Type: N, H10
[23565980]
Updated data: the explanted aus 800 device was visually inspected and functionally tested. No leak was found. The pump was not functionally tested due to blood inside pump. The balloon pressure tested at 57. 5 cmh2o. It was originally rated at 81-90 cmh2o. The balloon was returned with blood inside.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2015-00308 |
| MDR Report Key | 4919394 |
| Report Source | 01,05,FOREIGN,HEALTH PROFESSI |
| Date Received | 2015-07-16 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-06-30 |
| Date Mfgr Received | 2015-08-10 |
| Date Added to Maude | 2015-07-16 |
| 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 | 2015-07-16 |
| Returned To Mfg | 2015-08-10 |
| 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 | 2015-07-16 |