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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. MONOCRYL PLUS ANTIBACTERIAL SUTURES

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ETHICON, INC. MONOCRYL PLUS ANTIBACTERIAL SUTURES Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 08/18/2011
Event Type  Injury  
Event Description

It was reported that a patient underwent spinal surgery on (b)(6) 2011 and suture was used. During the surgery, screws between t5 and t7 were removed and the surgical incision was closed with suture. The patient experienced inflammation, redness, and extreme incisional pain of the wound. Immediately after the surgery, the upper right quadrant of the patient's back became hypersensitive, red and swollen. Six days after the surgery, the half inch area surrounding the incision turned red and was described as being on fire by the patient's mother. The mother of the patient stated that pieces of the suture protruding from the wound could be seen. The patient was seen by the operating orthopedic surgeon and the plastic surgeon who closed the incision. The patient was given a course of keflex even though incision infection was ruled out upon examination. The redness and the sensation of being on fire persisted. The patient had difficulty with activities of daily living because of the pain. The plastic surgeon opined the wound presentation was caused by the suture and has told the patient's mother that the reaction would dissipate once the suture absorption was complete.

 
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Brand NameMONOCRYL PLUS ANTIBACTERIAL SUTURES
Type of DeviceSUTURE
Manufacturer (Section D)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876
Manufacturer Contact
daniel lamont
route 22 west
po box 151
somerville , NJ 08876
9082182708
MDR Report Key2306155
Report Number2210968-2011-01634
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/28/2011
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: 10/25/2011 Patient Sequence Number: 1
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