MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 12INX14IN; MESH, SURGICAL, POLYMERIC

Catalog Number	SPMXXL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	09/21/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Adverse event involving tachycardia and erythema were submitted via mw 2210968-2014-15681.(b)(4).Adverse event involving wound erythema was submitted via mw 2210968-2015-10853.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.
Event or Problem Description
It was reported that a patient underwent a recurrent umbilical incisional hernia repair with mesh placed pre-peritoneal on (b)(6) 2014.It was reported that the patient developed erythema on 7 sept with no action; erythema related to the procedure, not related to the device.The patient developed tachycardia on 5 sept and stop 10 sept with no action indicated.Tachycardia related to the procedure, not related to the device.Patient developed tachypnea 6 sept and stop 7 sept with cxr revealing atelectasis.Tachypnea related to the procedure, not related to the device.It was also reported that the patient experienced abdominal wall infection requiring admission to an outside facility for treatment.The patient's post discharge course was complicated by the abdominal wall infection which required a hospitalization.The patient was admitted to the local hospital for 10 days for iv antibiotics and local wound care.The patient has recently finished her discharge course of antibiotics and is healing appropriately.The patient continues to receive every other day wound care by a wound care specialist.The infection began on (b)(6) 2014 and ended on (b)(6) 2014.This adverse event is possibly related to the product and definitely related to the procedure.It was also reported that the patient experienced tachypnea which is not related to the product, but definitely related to the procedure.

• Brand Name: PROLENE SOFT MESH 12INX14IN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1210 ward avenue; west chester PA 19380
• MDR Report Key: 9154426
• Report Number: 2210968-2019-88355
• Device Sequence Number: 2308086
• Product Code: FTL
• UDI-Device Identifier: 10705031050518
• UDI-Public: 10705031050518
• Combination Product (Y/N): N
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: SPMXXL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 10/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention