MAUDE Adverse Event Report: ETHICON INC. DERMABOND,HVD MINI US 12; ADHESIVE, TOPICAL SKIN

Catalog Number	DHVM12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested and the following was obtained: did the glass penetrate the user¿s skin? - no.What was done to treat the shard penetration? - nothing.Was medical or surgical intervention required? - no.Was there any special diagnostic test performed? - no.What is the status of the surgeon injury today? - no injury.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown ultrasound procedure on (b)(6) 2019 and topical skin adhesive was used.The adhesive tube had a shard attached to the tube.The physician was applying it and the physician's glove was cut.Case completed with another device of the same product code.There were no patient consequences reported.No device will be returned.

• Brand Name: DERMABOND,HVD MINI US 12
• Common Device Name: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8537063
• Report Number: 2210968-2019-80575
• Device Sequence Number: 2431714
• Product Code: MPN
• UDI-Device Identifier: 10705031203525
• UDI-Public: 10705031203525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: DHVM12
• Device Lot Number: MJH542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1