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

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); 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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (prolene polypropylene mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved? citation: gastroenterology.2015; 149: 296¿297.Doi: http://dx.Doi.Org/10.1053/j.Gastro.2015.03.049.(b)(4).

Event Description

It was reported in a journal article title : an unusual case of abdominal pain and diarrhea a (b)(6)-year-old woman with a background of primary hyperparathyroidism was referred by her endocrinologist for colonoscopy for a 5-month history of diarrhea and right-sided abdominal pain (diarrhea and right-sided abdominal pain).She reported sudden onset of abdominal pain with watery stools since a holiday in lanzarote, spain.Her past medical history consisted of a vaginal hysterectomy 2 years ago followed by tension-free vaginal tape procedure using prolene polypropylene mesh (ethicon) for stress incontinence.It was reported that the tension-free vaginal tape had eroded into the ascending colon.In view of the sudden onset of symptoms, it was suspected that it had occurred 5 months previously.The tape is not radiopaque, and so was not visible on ct after the procedure.The patient proceeded to undergo elective wedge resection of the colon.The tension-free vaginal tape procedure is minimally invasive and involves placing a synthetic mesh tape under the urethra with the ends of the mesh anchored to the lower abdominal wall.This results in urethral and bladder base support in patients with stress incontinence.In patients with a history of a tension-free vaginal tape procedure who present with pain or altered bowel habit, this diagnosis is one to consider, although this complication seems to be very rare.

• Brand Name: PROLENE POLYPROPYLENE MESH 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; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7932589
• MDR Text Key: 122625440
• Report Number: 2210968-2018-76308
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR