MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Not Applicable (3189)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The following additional information has been requested and the following has been obtained: was there any alleged product deficiency relating to the prineo? not that i am aware of.Was there any issue with the product non adherence to skin? not that i am aware of.Did the prineo product come off prematurely? not that i am aware of.Do you know what alternate device was used to reseal the patients wound? acquacel.Was the patient brought back to or to reseal the wound? no.How was each layer closed? fascia -symmetric, fat ¿ vicryl , skin ¿ monocryl.Please describe how was the adhesive was applied on the tape? i was not at the case.Were two prineo 22 products used on the patient? no.What prep was used prior to, during or after prineo use? during case, surgeon uses betadine as well as an analgesic injection.Was a dressing placed over the incision? if so, what type of cover dressing used? prineo was used.Please indicate any liquids that were injected during the procedure (antibiotics, pain killers)? during case, surgeon uses betadine as well as an analgesic injection.Was any type of ointment or cream applied to the incision? no ointment.Was the incision oozing or moist prior to application? no present in the case.Was the incision area clean and dry when the prineo was applied? no present in the case.Please explain what is meant by the ¿patients wound drained completely¿? postop the patient's wound drained with body fluid.When did the wound stop draining? after physician assistant applied another dressing¿named acquacel.What was the nature of the fluid? body fluid.Was any testing done on the fluid? not sure.Was there any wound dehiscence? not according to the pa if yes, how many layers dehisced? did the wound completely open? how was the patient treated (readmitted, reoperation, reclosure, another dressing)? another dressing.Please indicate any medical or surgical interventions performed? n/a.What is the physician's opinion of the contributing factors to the patient event? no feedback.What is the most current patient status? no updates.Do you have the lot number involved ? no.Is the product or representative sample (product from the same lot number) available for evaluation? no.Patient demographics: initials / id; age or date of birth; bmi ; gender? na.Patient pre-existing medical conditions? na.New user or experienced user? new.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 Description

It was reported a patient underwent an total hip replacement on (b)(6) 2019, and topical skin adhesive was used.Twenty four hours after the adhesive was applied to the patients wound drained completely out and soiled the patient and the patient's bed.An alternate unknown device was used to reseal the patient's wound.There were no patient consequences reported.No samples will be returned.Additional information was requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8769108
• MDR Text Key: 150420208
• Report Number: 2210968-2019-83745
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1