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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Model Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Fatigue (1849); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Chills (2191)
Event Date 07/09/2021
Event Type  Injury  
Event Description
It was reported a patient underwent a right anterior total hip arthroplasty on (b)(6) 2021 and topical skin adhesive was used. On (b)(6) 2021 [po # 12] nurse visit, adhesive removal with (b)(6). Fragile wound edge in two places. As if the edges had been too close together and the wound did not heal as seen on healthy skin. Clean with 0. 9% nacl. Well dried. (b)(6) without alcohol on and around. Skin prep all around. Steristrips up and down. On (b)(6) 2021 (post op day # 23), patient went to emergency visit patient had redness. Evolves rapidly during his stay in the emergency room. Chills, nausea, fatigue. No dlr, no stun, purulent discharge, thick blood serum superficial and deep pus: staph aureus. On (b)(6) 2021 (hospitalization). Surgery (b)(6): debridement / washing and change of liner and femoral head by dr. Closure with topical skin adhesive. Redness resolved post-op. Follow-up with microbio and aaiv [ancef iv then addition of rifampin po]. During the consultation with microbio: distal induration, user reports the lower part of the surgical wound. Additional information has been requested.
 
Manufacturer Narrative
(b)(4). Additional information: (b)(4). Device not returned. Additional information: according to home service: (b)(6) 2021 [po # 1] nurse phone clean dressing. (b)(6) 2021 [po # 4] physio no wound / dressing notes. (b)(6) 2021 [po # 5] nurse. Opov withdrawal, soiled 30%. Prineo in place, fine appearance. (b)(6) 2021 [po # 7] trp and inf, telephone reminders. Alright (b)(6) 2021 [po # 12] nurse. Prineo removal with (b)(6). Fragile wound edge in two places. As if the edges had been too close together and the wound did not heal as seen on healthy skin. Clean with 0. 9% nacl. Well dried. (b)(6) without alcohol on and around. Skin prep all around. Steristrips up and down. Then, 1st emergency visit (b)(6) 2021. According to emergency notes: emergency visit (b)(6) 2021 (po # 23). Onset of redness (b)(6) 2021. Evolves rapidly during his stay in the emergency room. Chills, nausea, fatigue. No dlr, no stun, purulent discharge, thick blood serum. Superficial and deep pus: staph aureus. (b)(6) 2021 (hospitalization). Surgery (b)(6): debridement / washing and change of liner and femoral head by dr. Closure with prineo. Redness resolved post-op. Follow-up with microbio and aaiv [ancef iv then addition of rifampin po]. During the consultation with microbio: distal induration, user reports the lower part of the surgical wound. Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Was prineo and/or stratafix used during the initial procedure? was prineo and/or stratafix used during the 1st revision? was prineo and/or stratafix used during during the 2nd revision? if so please provide which products were used and on which tissue layer. Did the patient experience a wound dehiscence? after the initial procedure? after the 1st revision? after the 2nd revision? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? lot numbers? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? how much and what type of drainage is present in this wound? no product is available for return. Note: events reported on mw# 2210968-2021-09541, mw# 2210968-2021-09542. Its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12615996
MDR Text Key283258635
Report Number2210968-2021-09540
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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