MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Unspecified Infection (1930); Pain (1994)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned for evaluation; analysis results indicate one cylinder and the reservoir performed within specifications.The other cylinder sustained a hole in the outer tube that appears to be caused by a sharp instrument; the cylinder remained functional.The pump was not functionally tested due contamination by what appears to be tissue.

Event Description

It was reported that following the implantation of his ams 700 inflatable penile prosthesis, the patient experienced infection."one month post-op ((b)(6)), patient presented with scrotal cellulitis and received 2 weeks of augmentin.Patient seen in surgeon's office for scrotal incision fluctuance.Patient returned 2 days later with open incision and drained purulent fluid, scrotal redness, firmness, scrotum and suprapubic area pain with symptomatic fever and chills.Wbc count 12,000.Patient was hospitalized and received broad-spectrum iv antibiotics for 72 hours.White count normalized and cellulitis resolved.Patient taken to surgery (b)(6) 2016 for salvage, washout with removal of prosthesis and washout and placement of an ams malleable prosthesis".Patient did well post-op and discharged to home in stable condition.No further patient complications were reported in relation with this event.

Manufacturer Narrative

Common device name from penile prosthesis to device, impotence, mechanical/hydraulic.Product code (fda) from fae to fhw.Pma/510(k) from k821628 to n970012.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5722405
• MDR Text Key: 47287237
• Report Number: 2183959-2016-00129
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 103