MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFOAM® ABSORBABLE GELATIN SPONGE, U.S.P.

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

The patient potentially had surgifoam placed inside a wound.In (b)(6) of 2021 the patient had a growth removed from the arm.The patient ended up with hematoma that was drained the next day and was packed with an item the patient believes to be surgifoam.Hereafter the patient had a lump in the arm that did not go away after months.The patient had it removed since it did not absorb after four months.The patient state that the patient will get medical records to see if it mentioned surgifoam.The patient wanted to know if the lack of absorption was normal of if the doctor used surgifoam correctly.The representative and the patient discussed uses and potential side effects.The patient stated the patient felt better having the information concerning the product.

• Type of Device: SURGIFOAM® ABSORBABLE GELATIN SPONGE, U.S.P.
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• MDR Report Key: 14546914
• MDR Text Key: 292968036
• Report Number: 3008478369-2022-00005
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• PMA/PMN Number: P990004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1