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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 UPA37615
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Additional information was requested and the following was obtained: please provide procedure name and date, open inguinal tuesday sept 7. Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail, no adverse consequences because the product was not used. How was procedure successfully completed? opened another device. Please provide status of product return. No return. The product was returned to ethicon inc for evaluation. Visual inspection was conducted on the returned device. Visual analysis of the sample received determined that one top foil packet and an opened folder with the product was received for evaluation. The foil was visually inspected, and excessive wrinkles and a hole that appeared to be caused by the wrinkles was noted. 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 will be conducted through complaint trending as part of post-market surveillance.
 
Event Description
It was reported that a patient underwent an inguinal hernia repair on (b)(6) 2021 and the mesh was used. It was reported that there was a pin-sized hole in the packaging of the device. 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 Key12585039
MDR Text Key281145128
Report Number2210968-2021-09271
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
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUPA37615
Device Catalogue NumberUPA37615
Device Lot NumberQCBCHSCO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device?

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