MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Anemia (1706); Edema (1820); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Urinary Retention (2119); Hernia (2240); Hematuria (2558); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.The single complaint was reported with multiple events.There are no additional details regarding the additional events.

Event Description

It was reported by clinical report from research study data that the patient underwent a hernia repair procedure on unknown date and the mesh was implanted.It was possible that the patient experienced bleeding peri-operative complication after the procedure with the use of the device and/or before the discharge of the index hospitalization, recurrent hernia re-operation within 90 days after the index hernia repair procedure, urinary retention peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization and/or edema peri-operative complication after the procedure with the use of the device and/or before the discharge of the index hospitalization.It was also possible that the patient experienced seroma, post-bleeding anemia, abscess, infection, orchitis, epididymitis and/or hematuria.There is no additional information available.

Manufacturer Narrative

(b)(4).Date sent to the fda: 01/10/2020.Corrected h-6 patient codes: 2597,2119,1820.Corrected b5 narrative: it was reported by clinical evaluation report from related research study data that the patient underwent a hernia repair procedure on unknown date and the mesh was implanted.It was possible that the patient experienced bleeding, urinary retention and/or edema as peri-operative complications after the procedure with the use of the device and/or before the discharge of the index hospitalization.There is no additional information available.The single complaint was reported with multiple events.There are no additional details regarding the additional events.

• Brand Name: ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9567497
• MDR Text Key: 185896969
• Report Number: 2210968-2020-00222
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 12/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention