MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P.; SURGIFOAM SIZE 100 (1974)

Model Number	1974
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Meningitis (2389)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our reference no.Is qn (b)(4).This report is considered initial and final.Based upon the article it is highly unlikely that surgifoam® sponge was the cause of one patient developing a nonsteroidal anti-inflammatory drug-induced aseptic meningitis and graft dehiscence requiring surgical revision.The authors have not used surgifoam® sponge according to the approved labeling, thus product was used off-label in this clinical context described in the article.This report is a repeat of mfr report # 3008478369-2018-00004 since the original mfr report was inadvertently overwritten by the importer for reporting a separate incident.
Event or Problem Description
This adverse event comes from an article: lam, f.C.Et al., augmented autologous pericranium duraplasty in 100 posterior fossa surgeries - a retrospective case series, operative neurosurgery, volume 71(2), december 2012; 302-307.Authors' background: the authors are working at division of neurosurgery, beth israel deaconess medical center, harvard university, boston, massachusetts, us.Study design: the objective with the case series is for the authors to report on their experience using locally harvested autologous pericranium as a dural substitute in patients who underwent posterior fossa surgeries.This is a retrospective case series of 100 patients who underwent elective suboccipital craniotomy at the beth israel deaconess medical center in the period from july 2005 to december 2011.Out of the 100 patients, the complication rate was 1% with 1 patient developing a nonsteroidal anti-inflammatory drug-induced aseptic meningitis and graft dehiscence requiring surgical revision.The authors note on page 306 ".We could demonstrate by allergen testing that our case of aseptic meningitis was due to an nsaid allergy and not secondary to reaction to the dural sealant".Our reference qn (b)(4).This event was originally reported as 3008478369-2018-00004.However, a maude search showed that this report number was inadvertently overwritten by the importer.

• Brand Name: SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P.
• Common Device Name: SURGIFOAM SIZE 100 (1974)
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 11086749
• Report Number: 3008478369-2020-00033
• Device Sequence Number: 2688405
• Product Code: LMF
• UDI-Device Identifier: 15712123000189
• UDI-Public: 15712123000189
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: Health Professional
• Device Model Number: 1974
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 12/29/2020
• 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