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Catalog Number PMH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Cramp(s) (2193)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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. Attempts are being made to obtain the following information.   to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Questions for patient: if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached. Questions for doctor: the patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of initial surgical procedure. The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? if applicable, will product be returned, return date, tracking information. What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? were any concomitant procedures performed? onset date/time of the pain from surgery. Location and character of the pain? is there any specific activity that precipitated the pain or eased the pain? what medical intervention was given for the pain management? results? if reoperation was performed please provide date and surgical findings was the device removed? if so, please date and details of the re-operation.
Event Description
It was reported that a patient underwent an incisional hernia repair surgery on (b)(6) 2015 and a mesh was implanted. It was reported that the patient became critically ill within 12 to 24 hours after surgery. It was also reported that it was resulting in 2 pneumonia's partial lung collapses and several fractured ribs which is 5 currently. It was reported that patient had flu like symptoms all the time spasms and cramping like labour contractions at the four anchor points. It was reported that it would last from half an hour to hours spasms then let¿s go after 30 to a couple of minutes. It was reported that the only thing is apply pressure to the areas affected the are hard to touch and breathe like in labour and the patient had 4 labours. As reported by the patient depending on severity the area that cramps are painful to touch and hit to touch with redness and inflammation for up to days for the most one anchor point is always tender to touch. The patient considered suicide in 2016. The patient reported that she does not have pain relief. The patient reported that she has spasms scar tissue builds up making them more painful and a potentially damaging and stretching. All these issue the patient had over 4 years. It was reported that the patient has been on antibiotics for several month. It was reported that when the patient is off antibiotics she is unwell with infections around the mesh area temperature flu like symptoms and aching in every joint. It was also reported by the patient that the mesh is killing her.
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Manufacturer (Section D)
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
MDR Report Key9205245
MDR Text Key162854862
Report Number2210968-2019-88665
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2016
Device Catalogue NumberPMH
Device Lot NumberDER836
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/17/2019 Patient Sequence Number: 1