MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-01-12 for AMS ACTICON NEOSPHINCTER 72401958 manufactured by American Medical Systems (mn).
[5304664]
It was reported the patient had her acticon system replaced due to recurring incontinence. No further patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[5456979]
Additional information received indicated the device was also removed due to fluid loss.
Patient Sequence No: 1, Text Type: D, B5
[12644305]
Balloon: model# 72402105, serial # (b)(4), expiration date 4/16/2015, manufacturer date 04/2010. Pump: model# 72402287, serial # (b)(4), expiration date 6/3/2015, manufacturer date 06/2010.
Patient Sequence No: 1, Text Type: N, H10
[13015835]
Analysis results the action device was visually inspected. There was a leak in the cuff pillow that was the result of wear at a fold. The pump and balloon were not functionally tested due to the cuff leak.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2015-00008 |
| MDR Report Key | 4409357 |
| Report Source | 01,05 |
| Date Received | 2015-01-12 |
| Date of Report | 2014-12-31 |
| Date of Event | 2014-11-04 |
| Date Mfgr Received | 2015-01-26 |
| Device Manufacturer Date | 2009-03-26 |
| Date Added to Maude | 2015-01-12 |
| 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 | 2015-01-12 |
| Returned To Mfg | 2015-01-26 |
| Catalog Number | 72401958 |
| Device Expiration Date | 2014-03-24 |
| 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 | 2015-01-12 |