MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-06-02 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[5922578]
It was reported that the patient had his action neosphincter removed and replaced due to fluid loss, "cuff. " there were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13416442]
(in order of cuff, pump, balloon): catalog #: 72401964, 72402287, 72402104; expiration date: 12/15/2015, 04/05/2014, 12/12/2017; serial #: (b)(4). (in order of cuff, pump, balloon): manufacture date: 6/26/2012, 04/09/2013, 01/02/2013.
Patient Sequence No: 1, Text Type: N, H10
[14148928]
Device evaluation: the acticon device was visually inspected. There was a leak in the cuff at the face/backing junction that was due to fatigue. The pump and balloon were not tested due to the leak.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2015-00218 |
| MDR Report Key | 4810950 |
| Report Source | 01,05 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-08 |
| Date of Event | 2015-05-08 |
| Date Mfgr Received | 2015-06-22 |
| Date Added to Maude | 2015-06-02 |
| 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 | 2015-06-02 |
| Returned To Mfg | 2015-06-22 |
| 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 | 2015-06-02 |