MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED TOPICAL SKIN ADHESIVE; ADHESIVE, TOPICAL SKIN

Catalog Number ANX12

Device Problem Reaction (1514)

Patient Problems Reaction (2414); Treatment with medication(s) (2571)

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent total laparoscopic hysterectomy and bilateral salpingo-oophorectomy on (b)(6) 2014 and topical skin adhesive was used on five incisions.Following the procedure, on (b)(6) 2014 the incisions were normal in appearance.On (b)(6) 2014, the patient experienced erythema with vesicles on all of the incisions.A portion of topical skin adhesive remained in the incisions and was removed.The patient experiences itching sensation and applies topical steroid not prescribed by the surgeon.

Manufacturer Narrative

(b)(4).The actual device batch number associated with this event is not known.The possible batch number is reported as follows: batch hje127.In addition, a review of the batch manufacturing records for the possible batch number was conducted and the batches met all finished goods release criteria.

• Brand Name: DERMABOND ADVANCED TOPICAL SKIN ADHESIVE
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 0075 4
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4259157
• MDR Text Key: 5014166
• Report Number: 2210968-2014-15895
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: ANX12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2014
• 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: 42 YR
• Patient Weight: 54