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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. GYNECARE TVT DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Model Number 810041B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 01/17/2005
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
 
Event Description
It was reported that a patient underwent a sling procedure on (b)(6) 2005 and mesh was implanted.The patient reported experiencing a catheter for 16 days, painful urination, pelvic pain, lower back pain, numbness in the left leg causing falls, chronic pain in the lower limbs (hip, knees, foot), severely inflamed obturator nerve causing almost permanent sciatic nerve burning and cramps/electric shocks like a discharge in several places of the body.The patient stated these ailments are continuous or alternating.The patient has tried seeing urologists, muscle physiotherapy in the leg, foot and back along with osteopathy to regain flexibility of the affected joints.The patient further reported falling due to numbness in the left leg which caused a double fracture.The patient takes the following drugs to alleviate the pain: cymbalta apo, naproxen, diclofenac, and alternating 500 mg tylenol during the day due to drowsiness from apo gabapentin.No further information is available.
 
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Brand Name
GYNECARE TVT DEVICE
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits godet 20
neuchatel 2000
SZ   2000
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12193742
MDR Text Key262650799
Report Number2210968-2021-06458
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031000322
UDI-Public10705031000322
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K012628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2021
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
Device Expiration Date04/30/2009
Device Model Number810041B
Device Catalogue Number810041B
Device Lot Number1199112
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2004
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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