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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number SPMH
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
 
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported by an attorney that the patient underwent a surgical procedure on (b)(6) 2015 and a mesh was implanted into the sub-muscular space to reinforce the diminished tissue. It was reported that the patient has experienced muscle loss, weight gain, continuous stomach pain especially when making any sort of contact with her stomach, loss of bowel function, increased diarrhea and stool related issues, and now must walk with a cane or a walk chair. No additional information was provided.
 
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Brand NamePROLENE POLYPROPYLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6721233
MDR Text Key106197814
Report Number2210968-2017-32983
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberSPMH
Device Lot NumberJBB929
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/18/2017 Patient Sequence Number: 1
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