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Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Swelling (2091); Reaction (2414); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Date sent to fda: 10/28/2016. (b)(4). Conclusion: to date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: do you know what degree of flexion the knee is in during application? 70 degree flexion how many patient events are involved? unknown was there any medical or surgical intervention performed? not given antibiotics and the dressing was not removed what dressings were placed on patient? unknown. Attempts are being made to obtain the following information. If further details are received at a later date a supplemental medwatch will be sent. Please describe closure technique between the capsule to skin? what is the procedure date? how was the device was used (what layer of tissue and how many layers applied)? what was the location and incision size of prineo application? what prep was used prior to prineo application? was the prep allowed to dry prior to prineo mesh application? please describe how the adhesive was applied on the tape? was the mesh placed over the entire length of the incision? was the dermabond liquid adhesive placed to cover the entire length of the mesh? did the prineo mesh extend beyond the patient incision? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and let dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? what date did the reaction occur on? what was done to address the reaction? what type of medication was used to treat the reaction? a. What was the dosage? b. When (date) was the medication administered? was the product removed? was another method used to close the incision? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? can you identify the product code and lot number of the product that was used? what is the physician¿s opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (ie. Allergies, history of reactions) was prineo previously used on the patient in a previous surgery? if yes what was the outcome of previous surgery?.
Event Description
It was reported that a patient underwent a total knee replacement procedure on an unknown date and topical skin adhesive was used. The patient is a small (b)(6) female, (b)(6) with no pre-existing medical conditions. The patient was sent home post op day 2 and swelling occurred over the next week. The patient developed blistering of the skin at and around the area the product was applied. Some of the blisters are dark and there is a pigmented/ abnormal skin appearance. The doctor reports that when applying the product he flexes the knee to 60-70 degrees and then sews it tight with 2-0 vicryl suture. The doctor uses 4-0 subcuticular running stitch. The blisters are managed by using an 18" needle to get the fluid out and then applying dressing. The patient was treated with keflex prophylactically. The patient required more post op wound care. There is no evidence of impaired healing or infection from the issue and the patient is reportedly doing well. The doctor opines that the amount of bleeding and swelling is the primary cause of the blistering and the tape not allowing seepage. Additional information has been requested.
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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 Key6064817
MDR Text Key58679283
Report Number2210968-2016-14571
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
Report Date 10/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
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 Received10/10/2016
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 Treatment Data
Date Received: 10/28/2016 Patient Sequence Number: 1