MAUDE Adverse Event Report: ETHICON INC. GYNECARE UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title: transvaginal repair of vault prolapse with full length polypropylene mesh at low cost.This study demonstrates the use of an improvised full length multi-tailed soft polypropylene mesh for vault prolapse which is cheap and with minimum complications.This is a case series of the use of mesh in 37 consecutive cases (mean age was 60 and age range: 45 to 78 years old) of vault prolapse treated by the author from february 2008 to december 2009.The gynemesh ps gynecare mesh was shaped from soft macroporous monofilament polypropylene available as sheets of 10 x 15 centimeters size.Three pieces of 3.3 centimeters width and 15 centimeters length were cut from each sheet and formed the central core.The full length mesh was laid to support the bladder, vault, and rectum.Reported complication included mesh erosion in 1 patient (anterior vaginal wall 3 cm above external urethral meatus).This patient did not have any symptoms and was also not sexually active.Hence, no action was taken to the event.It was concluded that the present technique with improvised mesh has given very good surgical results with very low complication rates and extremely high patient satisfaction.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7486570
• MDR Text Key: 107342202
• Report Number: 2210968-2018-72590
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2018

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: 04/06/2018
• Initial Date FDA Received: 05/04/2018
• 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