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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PROMESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Local Reaction (2035)
Event Date 07/04/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Date sent to the fda: 12/2/2020. (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. 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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported that a patient underwent an eventrorraphy procedure on (b)(6) 2020 and the mesh was implanted. It was reported that on (b)(6) 2020, the patient reported feeling well, with controlled pain, no fever, no emesis, satisfactory evolution. It was also reported that on (b)(6) 2020, the patient indicated that she had pain after surgical intervention associated with heat, redness and erythema, the day before she removed the drain. It was also reported that the patient had new paraclinics performed with pcr 22. 26, hb: 10. 4, platelets: 516000. It was reported that antibiotic treatment was started with cefazolin 2 g / 6 hours, tramadol 50 mg / 8 h, dipyrone 1 g / 8 h. It was reported that on (b)(6) 2020 the patient continued with the same management. It was reported that a review by a surgeon on (b)(6) 2020 indicated iso, with improvement in pain and heat, and collection was discarded. It was reported that enoxaparin 40 mg / sc / day was added. It was also reported that on (b)(6) 2020 a review by a surgeon indicated no peritoneal irritation, surgical wound in good condition, no secretions or bleeding. It was reported that with symptomatic and clinical improvement patient was given recommendations, warning signs, order of oral antibiotic, discharge and control appointment. (cephalexin 500 mg / 6 hours for 5 days).
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
MDR Report Key10933558
MDR Text Key219550278
Report Number2210968-2020-09498
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/02/2020 Patient Sequence Number: 1
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