MAUDE Adverse Event Report: ETHICON INC. ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE; STAPLE, IMPLANTABLE

Catalog Number	STRAP25R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ecchymosis (1818); Erythema (1840); Unspecified Infection (1930); Pain (1994); Seroma (2069); Abdominal Distention (2601)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a laparoscopic hernia repair procedure on (b)(6) 2023 and symbotex mesh (medtronic) was secured with absorbable straps and unspecified ¿disposable staples¿.The patient is now experiencing extreme pain.It is now 13 weeks post-surgery and she is still unable to function normally.On (b)(6) 2023, the patient was treated for infection on ward and the pic line was ruled out as a cause.On (b)(6) 2024, the patient underwent surgery to drain a 31mm seroma.On (b)(6) 2024, abdominal ultrasound was performed and reported a small superficial post-op seroma.On (b)(6) 2024, o/g pain was noted and the hernia surgeon requested ct abdo which reported fatty liver, abnormal kidney function, nil sign.Findings related to hernia.The patient reported bloodwork was normal (for her).On (b)(6) 2024, the patient reported ongoing significant pain (incl.On touch) and bloating in the morning.The patient saw the gp this day with view to obtaining referral to surgeon who operated on her in january for seroma.The patient reports that she does not want to see her hernia surgeon as she believes the surgeon is dismissive of her pain and has advised the patient to continue pain relief and do assigned abdominal exercises.The patient also has a pain specialist appointment in about one month.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report(s)? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information received: pt is seeing her respiratory specialist today.Pt is not currently under the care of a colorectal or general surgeon but a referral to a general surgeon to review her abdominal issues is being arranged.Pt reports possible abdominal ¿bleed¿ on (b)(6) 2023 incl.Abdominal redness and bruising.Pt has had a ct abdo and is expecting to receive her results on (b)(6) when she sees her spinal surgeon who is currently managing her neck condition and hernia case until general surgeon review.Pt reported that her spinal surgeon commented that the hernia repair in (b)(6) 2023 should not have been done laparoscopically (likely due to large defect size).Pt reports the symbotex mesh used in her surgery was 10x15cm in size.

• Brand Name: ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19084221
• Report Number: 2210968-2024-04181
• Device Sequence Number: 7621115
• Product Code: GDW
• UDI-Device Identifier: 10705031470552
• UDI-Public: 10705031470552
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Catalogue Number: STRAP25R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYMBOTEX MESH (MEDTRONIC)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown