MAUDE Adverse Event Report: COLOPLAST A/S GENESIS KIT 13 COATED; PENILE PROSTHESIS

Model Number	5192701400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report 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 or Problem Description
According to the available information, the genesis malleable was being removed due to patient preference, to implant an inflatable prosthesis.Upon incision into the corpora, the physician observed biofilm present in each corpora and on the malleable rods.Due to the infection, another malleable device was placed instead of the inflatable prosthesis.
Additional Manufacturer Narrative
This follow-up is created to document the returned device, corrected lot and conclusion of the investigation.Two malleable rods were received for evaluation.As examination of the device may not conclusively confirm or disprove the report of infection quality accepts the physician's observations as to the reason for surgical intervention.The review of the device lot history records indicates this lot passed sterility testing prior to being released.The device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than the device.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

• Brand Name: GENESIS KIT 13 COATED
• Common Device Name: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9176552
• Report Number: 2125050-2019-00847
• Device Sequence Number: 14363231
• Product Code: FAE
• UDI-Device Identifier: 05708932324809
• UDI-Public: 05708932324809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 5192701400
• Device Catalogue Number: 519270
• Device Lot Number: 5953118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 05/20/2020
• 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: 69 YR