MAUDE Adverse Event Report: COLOPLAST A/S GENESIS MALLEABLE; PROSTHETIC PENIS

Model Number 5192101000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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 available information, the (b)(6) patient with this device experienced t retropubic radical prostatectomy in 2004 for prostate adenocarcinoma with gleason 6 (3 + 3) pt2 n0 m0, with erectile deficiency and was unresponsive to drug therapy.And indication to al placement of malleable penile prosthesis.During the malleable prosthesis placement surgery, the left penile perforation occurred intercavernous septum (cross over).They continued the procedure.The positioning was achieved after having widened the length of the corpus tomia, the brevity of which was probably considered the main cause of the complication.They then remove the hegar dilator and place the second cylinder in the corpus cavernosum of left, thus achieving the set goal.The excellent result was confirmed at the follow-up.Perforation of the intercavernous septum during penile prosthesis placement it does not represent an absolute reason for interruption of the surgical procedure.The technique described by us allows the safe positioning of penile prostheses with excellent results functional and aesthetic at follow-up.

Manufacturer Narrative

B2 on the initial report indicated: hospitalization, intervention required, and death.Additional review determined the issue occurred during implant and did not result in extended admission to the hospital, subsequent intervention, and there was no patient death.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PROSTHETIC PENIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11944874
• MDR Text Key: 254630701
• Report Number: 2125050-2021-00677
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5192101000
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 70 YR