MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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

Patient Problems Erosion (1750); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Itching Sensation (1943); Pain (1994); Respiratory Distress (2045); Cramp(s) (2193); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure on an unknown date and mesh was implanted.The patient reported experiencing symptoms of mesh erosion, toxins causing ill health, allergic reaction, itchy spots, sore eyes, vertigo, pain in the upper arms, lower back, pelvic area, buttocks, upper thighs and lower abdomen, cramps, intermittent vaginal bleeding, pain on urination, loss of bladder control, tiredness, breathlessness and angina.The device remains implanted.No additional information is available.

• Brand Name: TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7507483
• MDR Text Key: 108084729
• Report Number: 2210968-2018-72746
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K100936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 04/12/2018

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: 04/12/2018
• Initial Date FDA Received: 05/11/2018
• 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