MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. AVITENE; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number UNKAA010

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

Based on the limited information provided, at this time no definitive conclusions can be made.Davol requested additional information from ethicon to determine when the event occurred and a complainant contact name.Ethicon responded that they were unable to provide any additional information.We did reach out to our distributor to see if additional information could be obtained.As reported one day post op the patient underwent an additional surgery to remove excess avitene.The ifu's for the avitene family of products were reviewed.The precautions section of the ifu states that, only that amount of avitene (mch) necessary to produce hemostasis should be used.After several minutes, excess material should be removed.This is usually possible without the reinitiation of active bleeding.Without a lot number a review of the manufacturing records is not possible.A 24 month period of review was performed and there have been no similar complaints reported during this time.If additional information is obtained, a supplemental mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

The following was reported to davol by (b)(4).It is reported that the patient underwent a l2/3, l3/4 and l4/5 posterior decompression and l2/3 spine hernia removal surgery.There was much bleeding from the epidural venous plexus around both l3 nerve root and avitene (microfiber collagen) was applied.On the second day after surgery, mmt2 paralysis was confirmed on the left iliopsoas muscle and quadriceps femoris muscle and re-operation was carried out, and the avitene was removed since there was a possibility of nerve root compression.Following the removal procedure the patient was able to walk by herself and the paralysis was gradually improved.

• Brand Name: AVITENE
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): MEDCHEM PRODUCTS, INC. -1223089; 160 new boston street; woburn MA 01801
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5334281
• MDR Text Key: 34666010
• Report Number: 1213643-2015-00437
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• PMA/PMN Number: PMA80002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR