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Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Reaction (2414); No Code Available (3191)
Event Date 12/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent.
Event Description
It was reported that the patient underwent total knee replacement procedure on an unknown date and topical skin adhesive was used. Approximately two weeks after the procedure, the patient presented with redness and blistering. There were no changes to the prep process used and the patient had used the device in the past with no reaction. Additional information has been requested.
Manufacturer Narrative
Additional information was requested and the following was obtained: what is the procedure date - schedule shows dates were either the (b)(6). How was the device was used (what layer of tissue and how many layers applied) - used on skin, over the closed incision. One layer of dermabond over the prineo tape. Tape completely covered with overlap on edges. Tape extended 1-2 cm past incisions. What was the location and incision size of prineo application. What prep was used prior to prineo application. Preop prep alcohol and chloraprep. Intraop no prep. Once incision closed, application area for prineo wiped down with sterile saline and dried prior to prineo application. Was the prep allowed to dry prior to prineo mesh application. See question 4 answer. Please describe how the adhesive was applied on the tape. Same method as over the last 12-13 months of use. Application area wiped clean with sterile saline and patted dry. Prineo tape applied over incision to ensure overlap of incision by 1-2 cm. One layer of dermabond applied uniformly over entire tape to include overlapping edges. Was the mesh placed over the entire length of the incision - yes. Was the dermabond liquid adhesive placed to cover the entire length of the mesh - yes. Did the prineo mesh extend beyond the patient incision - yes. Was incision re-prepped before closure - if so, with what - if so, was the prep allowed to dry - no re-prep. Was the skin prep solution wiped off and let dry before applying adhesive - wiped with sterile saline and patted dry. Was a dressing placed over the incision - if so, what type of cover dressing used - yes. Meplex border applied once dermabond dry to touch. What date did the reaction occur on - please answer. What does the reaction look like - please provide details. Please answer. How large of an area does the reaction cover - please answer. What was done to address the reaction - please answer. What type of medication was used to treat the reaction - please answer. What was the dosage. When (date) was the medication administered. Was the product removed? was another method used to close the incision - please answer. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde - none that aware of. Two patients had prineo used on opposite side previously with no issue. Is the patient hypersensitive to pressure sensitive adhesives - not that aware of. Were any patch or sensitivity tests performed - no. Can you identify lot number of the product that was used - no. What is the physician¿s opinion of the contributing factors to the reaction - please answer. What is the most current patient status - please answer. Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions) please answer. Was prineo previously used on the patient in a previous surgery - if yes what was the outcome of previous surgery - please answer for these 3 patient.
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Manufacturer (Section D)
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
MDR Report Key6274213
MDR Text Key65632893
Report Number2210968-2017-30359
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/24/2017
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 Treatment Data
Date Received: 01/24/2017 Patient Sequence Number: 1