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U.S. Department of Health and Human Services

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

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ETHICON INC. TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
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.
 
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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 Key7507483
MDR Text Key108084729
Report Number2210968-2018-72746
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K100936
Number of Events Reported1
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 Received05/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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