MAUDE Adverse Event Report: Ferrosan Medical Devices A/S SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.; Agent, Absorbable Hemostatic, Collagen Based

Model Number	1972
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the account contact to the sales rep that the patient had an allergic reaction on the sponge of the device.
Additional Manufacturer Narrative
No lot number is available.

• Brand Name: SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
• Common Device Name: Agent, Absorbable Hemostatic, Collagen Based
• Manufacturer (Section D): Ferrosan Medical Devices A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: . . ; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 50879951
• Report Number: 3008478369-2026-00036
• Device Sequence Number: 21317091
• Product Code: LMF
• UDI-Device Identifier: 15712123000158
• UDI-Public: 15712123000158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 1972
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown