• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

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   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4): the physician confirmed that the post-operative wound presentation was not infectious in nature and that the localized reaction is resolving. The physician does not plan to go back to the operating room to remove any sutures from the site because there is no suture left at the site.

 
Manufacturer Narrative

(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. The actual device involved in this event is unknown. There are two possible devices involved in the event as follows: monocryl (poliglecaprone 25) suture, monocryl plus antibacterial sutures.

 
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMONOCRYL PLUS ANTIBACTERIAL SUTURES
Type of DeviceSUTURE
Manufacturer (Section F)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876
Manufacturer (Section D)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876
Manufacturer (Section G)
NI
ni
ni
ni
Manufacturer Contact
daniel lamont
route 22 west
po box 151
somerville , NJ 08876
(908) 218 -2708
Device Event Key2327786
MDR Report Key2306155
Event Key2203051
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 Followup,Initial
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
Was The Report Sent To Manufacturer? No
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
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/25/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NI
-
-