MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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.Citation: int urogynecol j (2007) 18:1237¿1241; doi 10.1007/s00192-007-0346-4; published online: 27 march 2007.(b)(4).

Event Description

It was reported via journal article: ¿title: small bowel obstruction after vaginal vault suspension: a series of three cases¿ authors: beri ridgeway, matthew d.Barber, mark d.Walters and marie fidela r.Paraiso citation: int urogynecol j (2007) 18:1237¿1241; doi 10.1007/s00192-007-0346-4; published online: 27 march 2007.This case study presented a thorough review of the literature that revealed no previous reports of primary vaginal reconstructive surgery leading to small bowel obstruction (sbo) in female patients.In case 2, a (b)(6) multiparous woman with no previous abdominal surgeries presented to the urogynecology clinic with the complaint of symptomatic pelvic organ prolapse.During the surgery, one figure-of-eight stitch of 0-prolene and two figure-of-eight stitches of 0-pds were placed in the high uterosacral ligaments bilaterally and later attached to the vaginal cuff muscularis and epithelium, respectively.Bowel obstruction was noted and laparoscopy was performed revealing an area of small bowel caught in a prolene suture at the uterosacral ligament vaginal vault suspension site in the pelvis and a related bowel wall hematoma.In conclusion, the authors noted that a possible new trend of placing vaginal vault suspension sutures more proximal in the uterosacral ligament predisposes to small bowel obstruction.The patient¿s postoperative course was uncomplicated with the exception of a mild wound infection, which was treated with drainage and oral antibiotics.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7449851
• MDR Text Key: 106140472
• Report Number: 2210968-2018-72252
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

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: 03/27/2018
• Initial Date FDA Received: 04/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR