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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Discharge (2225); Reaction (2414); No Code Available (3191)
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. The following additional information was obtained: please describe how the adhesive was applied on the tape? they are applying prineo to a back incision and they start in the middle of incision and pat outwards. No stretching is involved. And the pen is applied across the length of the adhesive mesh the single complaint was reported with multiple events. There are no additional details regarding the additional events. Attempts are being made to obtain the following additional information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Is the total number of patients who have experienced reactions available? have any of the aforementioned events been previously reported to ethicon? is so, please provide the respective reference number for each case(s). For each individual patient event please provide the following information, if available: what is the procedure name? 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? how large of an area does the reaction cover? do you have any pictures of the reaction? is so please label each picture and the corresponding patient number (i. E. Patient 1 ¿ picture 1) 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 lot number of the product that was used? what is the physician¿s opinion of the contributing factors to the reaction? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. 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 the patient underwent an implant spine procedure on an unknown date and topical skin adhesive was used. The patient had a post op allergic reaction with blistering, pain, itching and redness. The patient returned before the two week post op visit to be treated and the topical skin adhesive was removed. Additional information has been requested.
 
Manufacturer Narrative
(b)(4). Additional information was requested and the following was obtained: is the total number of patients who have experienced reactions available - please provide specific number of cases and details for each case. - n/a. Have any of the aforementioned events been previously reported to ethicon - is so, please provide the respective reference number for each case(s). - no. N/a. For each individual patient event please provide the following information, if available: what is the procedure name - any back procedure including an implant. Ex. Tlif. Also, any case with certain comorbidities like obesity, elderly age, harder to heal tissues, etc. What is the procedure date - n/a. How was the device was used (what layer of tissue and how many layers applied) - dermabond prineo. Skin layer and only the skin layer. Usually use 1 prineo but if two applied then slightly overlap the two pieces. What was the location and incision size of prineo application - on the lower back across the incision and slightly extends beyond the incision, as indicated. Incision size varies by all the different procedure types. Has there been any difference in the wound closure process - no. What prep was used prior to prineo application - was the prep allowed to dry prior to prineo mesh application - normal prep. Wet saline lap to wipe away blood. Dry lap to wipe away wetness. Yes, they allowed it to dry. Please describe how the adhesive was applied on the tape - squeezed the bulb and drew the adhesive to the tape. One coat applied. 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 - slightly as indicated. Was incision re-prepped before closure - if so, with what - if so, was the prep allowed to dry - yes. Wet saline lap and dry lap. Yes. Was the skin prep solution wiped off and let dry before applying adhesive - yes. Was a dressing placed over the incision - if so, what type of cover dressing used - 4x4's over the prineo and with medipore tape. What date did the reaction occur on - when did you notice it was getting worse - this happened multiple times on multiple patients. The doctor has used this product over the last year. In the past six months it¿s been significantly more frequent. How large of an area does the reaction cover - it varies. Sometimes the reaction is just on the incision itself and sometimes it¿s so large it goes past the prineo tape. Do you have any pictures of the reaction - is so please label each picture and the corresponding patient number (i. E. Patient 1 ¿ picture 1) - n/a. What was done to address the reaction - either given medication, told the patient to take off, or seen the patient earlier than scheduled to remove the tape. To remove the tape, they just peel off slowly and get it wet if it is harder to remove. What type of medication was used to treat the reaction - benadryl (normal over the counter dosage). Hydrocortisone cream (normal over the counter dosage). Prednisone 12mg a day. Antibiotics specifically keflex 500mg four times a day (only prescribed if oozing or if wound is majorly affected). What was the dosage - please see above. When (date) was the medication administered - n/a. Was the product removed - was another method used to close the incision - it was removed if there was a major reaction. Depending on the stage of healing, either a dry dressing was applied or steri-strips were used. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde - not to their knowledge or the patient knowledge. Is the patient hypersensitive to pressure sensitive adhesives - not to their knowledge or the patient knowledge. Were any patch or sensitivity tests performed - no. Can you identify the lot number of the product that was used - n/a. What is the physician¿s opinion of the contributing factors to the reaction - the surgeon and staff believe prineo causes more reactions than dermabond advanced. He thinks the chemicals in advanced are less reactive than prineo. He realizes there are one off cases where there will be reactions as some patients might not know they are allergic to something in the chemicals. However, he is convinced that there have been more patients with reactions from prineo and that prineo has caused reactions that look worse than advanced. What type of patients are experiencing the reaction - what is the most current patient status - it varies. Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions) - n/a. Was prineo previously used on the patient in a previous surgery - if yes, what was the outcome of previous surgery - n/a.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6229877
MDR Text Key64071319
Report Number2210968-2017-30114
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
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 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
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 Received01/12/2017
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: 01/06/2017 Patient Sequence Number: 1
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