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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. UHS MESH 10CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. UHS MESH 10CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UHSL1
Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Additional information was requested and the following was obtained: please provide procedure name hernia. Please explain in detail what was the issue with the device. What do you mean by ¿mesh is deformed¿? the mesh is out of shape. Mesh has visible defects such as holes or tears? tears but no holes. Mesh erosion/exposure is reported? no. Mesh is not incorporated with tissue? yes. Mesh has a full or partial delamination or fraying? unknown. When was the mesh found deformed, before use on patient, during use on patient or after use on patient? during use. Please provide status of product return discharged. Please provide lot number" unknown.
 
Event Description
It was reported that a patient underwent a hernia repair on (b)(6) 2021 and the mesh was implanted. It was reported that during surgery, the mesh was deformed in that it had tears but no holes. It was also reported that the mesh was not incorporated with the tissue. There were no adverse patient consequences reported. Additional information was requested.
 
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Brand NameUHS MESH 10CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12646973
MDR Text Key276888315
Report Number2210968-2021-09797
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K071249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 10/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUHSL1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
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

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