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

Catalog Number APP6

Device Problem Reaction (1514)

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

Event Type  Injury  

Event Description

It was reported that a patient underwent knee ligament/tendon reconstruction on an unknown date and a topical skin adhesive was used.The patient developed a reaction after application.Adjunctive therapy was done and the reaction subsided.

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.

• 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: 4203489
• MDR Text Key: 4964679
• Report Number: 2210968-2014-14996
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: APP6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2014
• 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