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Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Necrosis (1971); Tissue Damage (2104); Reaction (2414); No Code Available (3191)
Event Date 08/02/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts have been made to retrieve the device. 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. Additional information was requested and the following was obtained: initial procedure date timeline of events: (b)(6) 2016; what additional reoperation was required: gastroc flap pending, plastic surgeon; do you have any pictures of the reaction: yes; did the skin reaction extend beyond the borders of the tape: yes; is the product or representative sample (product from the same lot number) available for evaluation: hospital product, no; was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure: no; how was the knee positioned during prineo application: 90 degrees; please describe how the adhesive was applied on the tape: one coat. Mesh fully coated just beyond edges; was the mesh placed over the entire length of the incision: yes; did the prineo mesh extend beyond the patient incision: yes, at least 1 cm; what was used to remove the prineo: forceps; what skin prep was used prior to prineo use: hibiclenz, alcohol; was the skin prep allowed to dry prior to prineo mesh application: yes; was incision re-prepped before closure? if so, with what, if so, was the prep allowed to dry: chloraprep and loban during surgery, then washed with betadine before applying mesh. Yes; how large of an area does the reaction cover: 4-5cm; was the site cultured? if so, what bacteria were identified: yes, no bacteria identified; were any patch or sensitivity tests performed: none; what is the most current patient status: partial skin thickness loss, flap pending with plastic surgeon; was a dressing placed over the incision, if so, what type of cover dressing used: 4x4, abd wound dressing, ted hosel lot number involved: trying to get lot from hospital purchasing; physical examination on (b)(6) 2016: mo major effusion. Medial aspect looks great. Laterally, she has three areas where plastic surgeon debrided the ruptured blisters. The medial most one is a little more dusky than the others. There is no active drainage. Calf is soft and nontender; what is the physicians opinion of the contributing factors to the reaction: within three months of adding prineo to his procedures, he¿s sent 8 patients for referral to a plastic surgeon for blistering and/or necrosis. Although some blistering occurs with the peristrips he used prior to using prineo, he feels that the blistering is occurring more often since. Of those 8 referrals, two had to be reoperated on and one was positive for infection. He wants to understand potential variables involved that may have led to these outcomes.
Event Description
It was reported that the patient underwent a total knee procedure on (b)(6) 2016 and the topical skin adhesive was used. Following the procedure, the patient experienced severe blistering, tissue damage and necrosis, and skin reaction extended beyond the patient incision. The physical exam on (b)(6) 2016 revealed no acute distress and no major effusion. The medial aspect looked great. Laterally, the patient had three areas where ruptured blisters were debrided. The medial most one was duskier than the others. There is no active drainage and a calf was soft and non-tender. It was also reported that there was tissue damage and necrosis present and the patient required a reoperation. Currently, the patient has a partial skin thickness loss and a gastroc flap procedure with a plastic surgeon is pending.
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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
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
MDR Report Key5930526
MDR Text Key54020637
Report Number2210968-2016-13309
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 08/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2016
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: 09/06/2016 Patient Sequence Number: 1