MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFLO HEMOSTATIC MATRIX WITH THROMBIN

Lot Number 248197

Device Problem Insufficient Information (3190)

Patient Problem Hemostasis (1895)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

The six events are all from the same hospital and from the same physician.The physician reported that hemostasis was not adequately achieved during six (6) separate patient procedures where surgiflo® hemostatic matrix kit with thrombin product code 2993 (abbreviated surgiflo® product code 2993) was used in tonsillectomy procedures.The physician stated that during the procedure, hemostasis was not achieved with the use of surgiflo® product code 2993; therefore, cautery was used to achieve hemostasis and complete the procedure.The initial reporting notes that no blood transfusion was required.Each patient is currently stable.In order to assess the adverse event, clinical questions have been asked.When answers have been received the adverse event will be re-assessed.As always it is recommended to consult with the enclosed instructions for use (ifu) prior to the use of any medical device, in particular sections as the intended use/indications, contraindications, warnings and precautions.As per the surgiflo® product code 2993 ifu surgiflo® product code 2993 "is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical." as per the warning section: "surgiflo® hemostatic matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis." this report covers patient 3 of 6 patients.Single use product.

Event Description

"it was reported by the customer that during a tonsil procedure, there was more bleeding than usual after applying the product.It is unknown how the procedure was completed.It is unknown how the bleeding was controlled.No blood transfusion was required.The customer stated that the patient is currently stable." "it was reported that the physician experienced inadequate achievement of hemostasis after the use of surgiflo during a tonsillectomy procedure.The physician stated that he experienced this issue in a total of 6 separate tonsillectomy procedures, all of which took place on (b)(6) 2016.There is a total of 6 separate patients involved (specific patient identifier information (patient initials, dob, weight, etc).Has been requested)." this report cover patient 3 out of 6 patients.(b)(4).Best regards, (b)(6).

Manufacturer Narrative

The six events are all from the same hospital and from the same physician.The physician reported that hemostasis was not adequately achieved during six (6) separate patient procedures where surgiflo hemostatic matrix kit with thrombin product code 2993 (abbreviated surgiflo product code 2993) was used in tonsillectomy procedures.The physician stated that during the procedure, hemostasis was not achieved with the use of surgiflo® product code 2993; therefore, cautery was used to achieve hemostasis and complete the procedure.The initial reporting notes that no blood transfusion was required.Each patient is currently stable.In order to assess the adverse event, clinical questions have been asked.When answers have been received the adverse event will be re-assessed.As always it is recommended to consult with the enclosed instructions for use (ifu) prior to the use of any medical device, in particular sections as the intended use/indications, contraindications, warnings and precautions.As per the surgiflo product code 2993 ifu surgiflo product code 2993 "is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical".As per the warning section: "surgiflo hemostatic matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis".This report covers patient 3 of 6 patients.The 2th of december 2016: this is to be considered our final reporting.Thank you.Best regards (b)(6) qa technician biomaterials ferrosan medical devices a/s (b)(6).

Event Description

"it was reported by the customer that during a tonsil procedure, there was more bleeding than usual after applying the product.It is unknown how the procedure was completed.It is unknown how the bleeding was controlled.No blood transfusion was required.The customer stated that the patient is currently stable." "it was reported that the physician experienced inadequate achievement of hemostasis after the use of surgiflo during a tonsillectomy procedure.The physician stated that he experienced this issue in a total of 6 separate tonsillectomy procedures, all of which took place on(b)(6) 2016.There is a total of 6 separate patients involved (specific patient identifier information (patient initials, dob, weight, etc).Has been requested)." this report cover patient 3 out of 6 patients.(b)(4).Mdr no.: 3008478369-2016-00006.Best regards, (b)(6) qa technician biomaterials ferrosan medical devices (b)(6).

• Brand Name: SURGIFLO HEMOSTATIC MATRIX WITH THROMBIN
• Type of Device: SURGIFLO HEMOSTATIC MATRIX WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• Manufacturer Contact: majbrit andersen ; sydmarken 5; soeborg, denmark 2860 ; DA 2860
• MDR Report Key: 5989716
• MDR Text Key: 55990082
• Report Number: 3008478369-2016-00006
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Lot Number: 248197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 4 YR