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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO ADVANCED MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO ADVANCED MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UPA31015
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
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. A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Evaluation: one unopened sample of product was returned for evaluation. Upon visual inspection of the returned sample, the foil was inspected and multiples holes in the cavity and were noted. In addition, the foil was observed with marks that appears to be caused by a pen. Due to the damages found on the device, a possible cause for these conditions is due to improper handling during transit or storage. As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch. Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance. Additional information was requested and the following was obtained: please explain in detail how was the primary package defective? was there any hole, tear, or puncture that compromises sterility? any open or incomplete seal? foil packaging of mesh shows a series of punctiform indentations. It is unclear, whether the foil actually perforated. Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail: issue was detected pre op, therefore no harm to patient how was procedure successfully completed? with new mesh. Please provide status of product return: product is in transit to loc.
 
Event Description
It was reported that a patient underwent a hernia repair on an unknown date in 2021 and the mesh was used. Prior to surgery, it was found that the primary packaging was defective. It was reported that the foil packaging of the mesh showed a series of punctiform indentations, but it was unclear whether the foil actually perforated. A like device was used to successfully complete the procedure. There were no adverse patient consequences reported. Additional information was requested.
 
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Brand NameULTRAPRO ADVANCED
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12740915
MDR Text Key284970605
Report Number2210968-2021-10660
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K070224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUPA31015
Device Catalogue NumberUPA31015
Device Lot NumberQLBCDKD0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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