MAUDE Adverse Event Report: COLOPLAST A/S SAFFRON FIXATION SYSTEM; PELVIC LIGAMENT FIXATION SYSTEM

Model Number 5203401400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and 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 Description

According to available information, this device required a transfusion due to a hematoma.It was noted implantation was an uneventful procedure.Post-operation, a hematoma was discovered by cta and hemoglobin dropped to 6.The patient received a transfusion.Physician suspects dissection vascularity.No other adverse patient effects were reported.

• Brand Name: SAFFRON FIXATION SYSTEM
• Type of Device: PELVIC LIGAMENT FIXATION SYSTEM
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15840762
• MDR Text Key: 304079727
• Report Number: 2125050-2022-01284
• Device Sequence Number: 1
• Product Code: PBQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 5203401400
• Device Catalogue Number: 520340
• Device Lot Number: 8808031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2022
• Initial Date FDA Received: 11/21/2022
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention