[185781499]
The lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue. No photographs or samples were available for review. Without the finished good lot number, retained samples could not be reviewed. If samples, photos or additional information becomes available at a later date, the samples or information will be reviewed and added to the file. A revised response letter will be forwarded to you at that time. Without sterile devices to visually inspect or to pull test, magnified photos of the dehisced wound, product code, lot number, material type, or receiving detailed information regarding the pre-operative preparation of the devices, procedure performed, placement of the device in the tissue, surgeon? S technique, or the patient? S health status, or quality of the tissue, a definitive root cause for the reported event cannot be confirmed with certainty. As stated in the ifu for the devices,? Adverse events including wound dehiscence and reactions are common risks/complications of any surgical procedure. There are many causes that can result in the wound opening, sutures failing or reaction, infection, abscess/leakage during or post-operative a procedure: the patient? S health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition. The surgical procedure? The risk increases with poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of suture used for a particular procedure. Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise and heavy lifting. The journal article was forwarded to surgical specialties corporation from our distributor indicated there were several different products used in the procedure and does not specifically state that the stratafix caused the wound dehiscence. In conclusion, the study does not recommend the routine use of the prineo in the absence of deep dermal and/or subcutaneous/subcuticular sutures.
Patient Sequence No: 1, Text Type: N, H10
[185781500]
A clinical study was forwarded by our distributor which indicated a spinal wound closure using a self-adhering mesh system and polymeric glue (2-oca). During the procedure, fascial layers were closed using stratafix knotless barbed suture (ethicon) and superficial layers were closed using dermabond prineo (ethicon). Reported complication included wound dehiscence (n=1) which the patient developed within 48 hours requiring a return to theatre for washout and primary closure under general anaesthetic. In conclusion, the study did not recommend the routine use of the prineo in the absence of deep dermal and/or subcutaneous/subcuticular sutures.
Patient Sequence No: 1, Text Type: D, B5