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

Catalog Number ANX12

Device Problem Reaction (1514)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Reaction (2414); Treatment with medication(s) (2571)

Event Date 03/13/2015

Event Type  Injury  

Manufacturer Narrative

A review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Batch hlh356, mfg.Date 10/27/2014, exp.Date 09/30/2016.Batch hlj017, mfg.Date 10/31/2014, exp.Date 09/30/2016.Batch hlr576, mfg.Date 10/22/2014, exp.Date 09/30/2014.

Event Description

It was reported that the patient underwent spine implant removal procedure on an unknown date and topical skin adhesive was used.Approximately two days following the procedure, the patient experienced redness.The patient was prescribed rinderon and discharged from the hospital.The surgeon opined the patient may have experienced contact dermatitis.It was reported that the event is resolving.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch hlh356, batch hlj017, batch hlr576.

• 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: 4662004
• MDR Text Key: 13380322
• Report Number: 2210968-2015-03966
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ANX12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 20 YR