MAUDE Adverse Event Report: TITAN OTR INFRA 18CM; INFLATABLE PENILE PROSTHESIS

Device Problems Break (1069); Corroded (1131); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Fever (1858); Hypothermia (1915); Swelling (2091); Thrombosis (2100); Injury (2348); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This report is a follow-up to an event that was originally reported on asr exemption e2006011 in (b)(6) 2011.The report was created to document the additional event information received.

Event Description

This report is a follow-up to an event that was originally reported on asr exemption e2006011 in (b)(6) 2011.According to the available information received in 2011, this inflatable penile prosthesis was implanted on (b)(6) 2009.Later, the end user claimed the hospital stated that the surgery wasn't done correctly, that the spring in the release valve broke and damaged his colon.He said he had blood clots in his legs, that require him to be on numerous blood thinners and medications.He is also claiming the new implant does not extend to the tip of his penis.Additional information was received in 2019: the patient experienced back pain and difficulty walking.The patient also noted that the ipp had "busted and come apart inside me" and "they had to do emergency surgery".Patient stated that the physician implanted another ipp but the patient "felt the same reservoir".Patient claimed the physician implanted it backwards the first time.The patient also stated, the patient's wife had to take him to the hospital and that the pump "had busted." he noted "it" started turning black.They had to explant it and "cut me all to pieces" to remove the ipp that was "rusted and corroded".They had to give him 20 bags to cool his body down and "shoot my heart with an injection to keep me alive." they warmed him to 94 degrees, and he wasn't breathing, but then had a temperature of 105 degrees.They put him on a "breathing machine." he then stated he "really didn't know what happened after he got to the hospital." the patient then noted how his "gonads swelled up" and how a 1.5 inch incision was made.The patient then stated that the surgeons, who sterilized him, were not supposed to implant the pump due to spinal stenosis.Per telephone conversations with coloplast, the patient indicated that he lost approximately 4 inches of penile length.It was unclear what date(s) the above events happened, and additional information is not available at this time.

• Brand Name: TITAN OTR INFRA 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 9405136
• MDR Text Key: 169789688
• Report Number: 2125050-2019-01097
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1