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Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Itching Sensation (1943); Tissue Damage (2104); Reaction (2414); Not Applicable (3189); No Code Available (3191)
Event Date 07/24/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The patient's pre-patellar bursa was aspirated on (b)(4) 2017. Purulent fluid, positive cultures, patient taken to or on (b)(4) 2017 for open incision and drainage. The patient was started on iv vancomycin. The patient was then brought back to the or on (b)(4) 2017 for a second open incision and drainage and poly exchange. The patient is being seen by infectious disease and on iv antibiotics in the hospital waiting on picc line and discharge.
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: how was the device applied to the incision? with knee flexed at 50 degrees. Please describe how the adhesive was applied on the tape? "painted on with the derma bond applicator supplied in the prineo kit. What prep was used prior to product application? chloraprep and the isopropyl alcohol. What was the location and incision size of the application? incision was ~20 cm vertical midline over anterior knee. Was a dressing placed over the incision? if so, what type of cover dressing used? after prineo a tell was placed after the derma bond dried then an ace wrap was applied. Please explain how the skin layers were closed to reduce skin tension? these were not tension blisters, they were small red papules that itched then formed small blisters but the skin was closed with inverted 2-0 vicryl <6 mm apart followed by the prineo. What date did the reaction occur on? on (b)(6) 2017 it was reported but began 1-2 days prior to reporting. What does the reaction look like and how large of an area does the reaction cover? it covered sporadically and involved 30% of the bodies surface and it is resolved now with only minor cosmetic deformities of the incision line now. Do you have any pictures of the reaction? yes. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Yes, product removed, medrol dose pak and keflex prescribed. Can you identify the product code and lot number of the product that was used? product code listed, lot number not recorded. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no - patient had a total knee replacement on the other knee 3 months prior with same prep, procedure, application of prineo - without any reaction. Was the patient exposed to similar products, such as artificial nails? no. What is the most current patient status? minor cosmetic deformities of the incision line. Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions) (b)(6), allergies: tramadol. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes - patient had a total knee replacement on the other knee 3 months prior with same prep, procedure, application of prineo - without any reaction.
Event Description
It was reported that a patient underwent a left knee replacement on (b)(6) 2017 and topical skin adhesive was used. On (b)(6) 2017 the patient returned to the doctor, complaining of blistering, oozing, and itching all over the body. The reaction covered sporadically and involved 30% of the bodies surface. The doctor removed the topical skin adhesive and prescribed medrol dose pak, keflex and benadryl. The reaction is now resolved with only minor cosmetic deformities of the incision line. The patient is currently doing fine. The patient had a previous total knee replacement on the other knee 3 months prior with same prep, procedure, and application of topical skin adhesive, without any reaction. Additional information was requested.
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Manufacturer (Section D)
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
road 183, jm. 8.3
san lorenzo PR 00754 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
MDR Report Key6825994
MDR Text Key105903921
Report Number2210968-2017-70099
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/28/2017 Patient Sequence Number: 1