MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problems Migration (4003); Material Split, Cut or Torn (4008)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown foot surgery on an unknown date and the mesh was implanted.It was reported that the surgical mesh was implanted in the patient's foot for a torn tendon.It was reported that over time some broke loose and migrated to the patient's toes.It was reported that the patient's body is rejecting the mesh.It was reported that there has been an open wound down by the patient's toes.It was also reported that an er physician removed a piece protruding out of the wound in the patient's big toe.It was reported that the patient has been treated with doxycycline and multi rounds of iv antibiotics.Additional information has been requested.

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.(b)(4).Device not returned.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? 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.

Manufacturer Narrative

Date sent to the fda: 5/5/2022.Additional b5 narrative: it was reported that the patient experienced infection following surgery.

Manufacturer Narrative

Date sent to the fda: 7/12/2022.Additional b5 narrative: it was reported that the patient underwent open right peroneal brevis tendon repair and tenosynovectomy on (b)(6) 2011 and mesh was implanted.It was reported the patient experienced swelling and pain in the toe.Date sent to the fda: 7/12/2022.

• Brand Name: VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14186488
• MDR Text Key: 289865571
• Report Number: 2210968-2022-02872
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male