MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROT ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number	ESR9162400
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional 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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the physician removed an otr device and replaced all components.There was a fluid loss of unknown cause in original device.
Additional Manufacturer Narrative
Requests for the explanted prosthesis and for additional information surrounding this event have been made.However, to date neither the device nor the information has been received.Without the benefit of analyzing the explant and without the requested information, quality cannot comment on the condition of the device or the events surrounding this incident.If the explanted device or additional information is received, quality will re-evaluate this event in accordance with procedures.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 3662619.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.
Event or Problem Description
Additional information received indicated flat pump - unable to inflate prosthesis.

• Brand Name: (2BO)TITAN OTR SCROT ZERO ANG
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7804412
• Report Number: 2125050-2018-00614
• Device Sequence Number: 13862369
• Product Code: FHW
• UDI-Device Identifier: 05708932487641
• UDI-Public: 05708932487641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ESR9162400
• Device Catalogue Number: ESR916
• Device Lot Number: 3662619
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR