MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of minimal access surgery | september 2006 | volume 2 | issue 3.(b)(4).

Event Description

Title: tapp - stuttgart technique and result of a large single center series.The study aimed to present the result of a large single center series of transabdominal preperitoneal (tapp) hernia repair.Between apr1993 and dec2005, a total of 12,678 with all types of hernia who underwent hernia repairs using tapp repair, both primary hernia (n=10,962; median age of 59 years [ranged 17-97 years]; median bmi of 25) and tapp after anterior repair(n=1,590; median age of 61 years [ranged 18-92 years]; median bmi of 25), were included.In the procedure, by using two clips (endopath hernia stapler, ethicon), the mesh should be fixed to the symphysis and cooper¿s ligament.Two clips are placed on the rectus muscle medial to the epigastric vessels and two clips at the transverse fascia located lateral to the epigastric vessels.As soon as the mesh was placed in position, the peritoneal incision should be approximated using an absorbable, industrially manufactured suture, whose ends get fixed with absorbable clips (lahodny-suture, ethicon).Intraoperative complications included injury to lateral femoral cutaneous nerve (n=33), inguinal bleeding (n=?) and other (n=8).Postoperative complications included bleeding (n=34), seroma (n=14) requiring reoperation, allergic reaction (n=5) and wound infection (n=6).Long term complications included persistent seroma (n=6), chronic pain (n=6) and other (n=3).Laparoscopic hernia repair can be performed successfully in clinical practice even by surgeons in training.Precondition for the success is a strictly standardized operative technique and a well-structured educational program.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10045875
• MDR Text Key: 191681020
• Report Number: 2210968-2020-03858
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1