MAUDE Adverse Event Report: ETHICON INC. TABOTAMP SNOW ABS; HEMOSTATIC AGENT, ABSORBABLE

Catalog Number T2091

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Paresis (1998)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? patient demographics: citation: acta neurochirurgica (2018); 160:2069¿2075.Doi: https://doi.Org/10.1007/s00701-018-3663-0.

Event Description

It was reported via a journal article: title: intracranial foreign material granulomas after cranial surgery authors: shadi al-afif, gokce hatipoglu majernik, elvis josef hermann, majid esmaeilzadeh, christian hartmann, joachim k.Krauss citation: acta neurochirurgica (2018); 160:2069¿2075.Doi: https://doi.Org/10.1007/s00701-018-3663-0.The authors presented a series of 12 patients with tumefactive foreign body granulomas after prior cranial surgery documented over a period of 13 years.A total of 12 patients (6 male and 6 female; mean age: 51 years; age range: 11¿68 years) with foreign body granulomas induced by synthetic material used in a prior surgery were identified.Patient 8, a 54-year old male patient who underwent removal of a frontal lobe hematoma and used oxidized cellulose polymer (tabotamp; ethicon) and developed foreign body granuloma with symptoms of progressive hemiparesis in all cases, total resection of the granuloma was achieved using departmental standard techniques for microsurgery, navigation, and monitoring.Mr imaging studies with gadolinium at follow-up showed no recurrence of the foreign body granulomas in all instances.Symptoms improved in all symptomatic patients.Despite its rarity, foreign body granuloma should be taken into consideration in the differential diagnosis of intracranial mass lesions especially in cases of suspected tumor recurrence after prior surgery.

• Brand Name: TABOTAMP SNOW ABS
• Type of Device: HEMOSTATIC AGENT, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9258430
• MDR Text Key: 167672159
• Report Number: 2210968-2019-89278
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2019

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 Operator: Health Professional
• Device Catalogue Number: T2091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR