MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROTAL 18CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR9181400

Device Problem Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 10/19/2018

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 the available information, patient didn't like pump, too big.Tubing close to pump frayed.The implant is not available for return.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.The device is not available for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to 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 2053522.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

• Brand Name: (2BO)TITAN OTR SCROTAL 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8122038
• MDR Text Key: 129021701
• Report Number: 2125050-2018-00865
• Device Sequence Number: 1
• Product Code: FHW
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QSR9181400
• Device Catalogue Number: QSR918
• Device Lot Number: 2053522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR