MAUDE Adverse Event Report: ETHICON INC. ETHISORB UNKNOWN; ABSORBABLE, SYNTHETIC PATCH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 product ethisorb caused and/or contributed to the adverse events described in the article? can specific patient demographics be provided for the subjects of this article? if so, please also include: patient initials, initial procedure date, pre-existing conditions, specific medical/surgical intervention per patient.Is the product code and lot number available for any of the ethicon devices used? citation: oral surg oral med oral pathol oral radiol endod 2003;95:16-22.Doi:10.1067/moe.2003.11.

Event Description

It was reported in a journal article that the patient underwent an orbital floor fracture reconstruction procedure on an unknown date and a patch was used.Inclusion criteria were patients between 18 and 60 years of age with maximum-size fractures of the orbital floor of 2x2 cm.Follow up was performed at preoperative, postoperative, 3 months, 4-11 months, 12-15 months, and 15-24 months intervals.The patient possibly experienced exophthalmos, enophthalmos, reduced bulbus/ motility, and or diplopia.Treatment of the events was not reported.Inflammatory reactions could be responsible for adhesions of the ocular muscles.Such adhesions could cause a reduction of bulbus motility that could also result in diplopia.Bulbus motility, diplopia, exophthalmos, and enophthalmos do not depend only on the size of an orbital floor defect or the material that was used for reconstruction.Concomitant injuries of the orbital walls or injuries of the eyeball also influence these factors.Additional information has been requested.

• Brand Name: ETHISORB UNKNOWN
• Type of Device: ABSORBABLE, SYNTHETIC PATCH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC. GMBH; p.o. box 1409 d22841; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7116614
• MDR Text Key: 94802607
• Report Number: 2210968-2017-71772
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2017
• 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