MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89222400

Device Problems Inflation Problem (1310); Free or Unrestricted Flow (2945); Pumping Problem (3016)

Patient Problems Discomfort (2330); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, after implant the patient experienced some auto inflation.The coloplast representative who attended the implant surgery stated there were no issues noted during the surgery.Per patient, after leaving the hospital and picking up prescriptions, four hours into his drive home, he began "crashing." the patient went to the hospital and had a cat scan, and an ilius was noted.While in the hospital the patient stated his penile implant auto deflated.The patient complained of the pump being hard and that his scrotum was tender.The patient noted being able to feel the tubing and difficulty with pumping.He stated he pumped the implant 12 times, which produced minimal movement.The device remains implanted.

• Brand Name: TITAN SCROTAL ZERO ANG 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 9351325
• MDR Text Key: 167312838
• Report Number: 2125050-2019-01042
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487382
• UDI-Public: 05708932487382
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89222400
• Device Catalogue Number: ES8922
• Device Lot Number: 6891549
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR