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U.S. Department of Health and Human Services


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Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional evaluation summary: representative samples were returned for analysis. From the results and observations, it can be concluded that mesh patches evaluated for setting time did not meet the design requirement. 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. Did 1 prineo not adhere during the procedure? it is believed the bottom/distal portion did not adhere was a second prineo applied to complete the procedure? no- not the initial procedure please confirm that the second prineo that was applied adhered properly to complete the procedure? correct- once patient came back. The second prineo was adhered. Did the product come off in the post operative time? if yes, please provide timeline yes- day 3 the bottom was not adhered. Please provide additional information on the wound site preparation: what prep was used prior to, during or after prineo use? cloraprep was a dressing placed over the incision? if so, what type of cover dressing used? 4 by 4¿s was the product applied to a wet surface? no was there any application of other topical compounds post product application (ie. Ointments, petroleum jelly and medications)? no patient post op care of the wound / product site? normal- patient went home with prineo post op care information what in the physicians opinion were the contributing factors to the product coming off post operatively? unknown patient demographics: initials/id; age or dob; gender; bmi - unknown update to patient current condition patient doing fine.
Manufacturer Narrative
The actual device batch number associated with this event is not known. The possible batch numbers are reported as follows: batch (b)(4), mfg. Date - 06/13/2017; exp. Date - 05/07/2019. Batch (b)(4), mfg. Date ¿ 07/27/2017; exp. Date - 6/26/2019. In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria. The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event Description
It was reported that the patient underwent a knee surgery on an unknown date and topical skin adhesive was used. Post operatively, the topical skin adhesive did not adhere properly and the patient returned for a wash out, due to continued oozing. After the wash out the patient was reclosed with suture and topical skin adhesive. All cultures came back negative for bacteria. The patients wound is healing fine. No further information is available.
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Manufacturer (Section D)
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
road 183, km. 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
MDR Report Key7010051
MDR Text Key106615059
Report Number2210968-2017-70824
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Yes
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: 11/08/2017 Patient Sequence Number: 1