The lot number was not reported so a batch review of the finished good lot and components could not be reviewed to determine if there were quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection process.Samples were not available for review.Without the finished good lot number, retained samples could not be reviewed.If samples, or additional information becomes available at a later date, the samples or information will be reviewed and added to the file and a follow-up report will be filed.Without receiving a finished good lot so manufacturing records could be reviewed, receiving sterile devices to tensile test, receiving photo¿s of the surgical site or receiving detailed information regarding the pre-operative preparation of the devices, placement of the device in the tissue, method utilized to secure the device in the tissue as stated in the ifu, surgeon¿s experience and/or technique, the patient¿s health status and specifics, quality of the tissue, post-operative events that may have occurred that may have affected the healing of the wound, culture results to identify the type of infection, 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 warning in the ifu states, ¿this an absorbable material, the use of supplemental non absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support.
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Our distributor received additional information from the end user who indicated there were no culture results.The patient did not have any patient risk factors.The patient did not fall or injure themselves and was compliant with post-operative instructions.The patient¿s current health status: a scar formed on the tissue on several points along the wound, in some points on the healed wound there are small residual granulating spots still in the evolutionary phase.The surgeon is experienced and works in a high-volume center.There was no change in the technique.The patient was operated on (b)(6) and is still under control.The patient had wound dehiscence after about 3 weeks on some points of the suture line.Some stitches were removed, and the suture was redone but subsequently they had to incise the wound to purge pus and exudate and closed with surgical staples.Patient also treated with deltacortene and bentalin beta cream.
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