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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

It was reported via journal article, ¿collagen-coated vicryl mesh is not a suitable material for repair of diaphragmatic defects¿ that collagen-coated mesh (ccvm) was used in the repair of diaphragmatic defects in a patient.The mesh was used as a reinforcement of the resutured muscle flap on a full-term baby girl that was admitted with a left congenital diaphragmatic hernia (cdh).At the time of her initial operation, she had agenesis of the left hemidiaphragm.She underwent multiple repair of the hernia due to multiple recurrences.Five years later, she was again admitted with recurrent cdh.During operation, a defect in the medial side of the flap was noted.The muscle flap was mobilized and was sutured to the central tendon of the diaphragm.The repair was reinforced by a sheet of ccvm that was stitched over the repair line.She made an uneventful postoperative recovery.The chest x-ray showed an intact diaphragm.At the last follow-up (8 months postoperatively) she was asymptomatic, but her chest x-ray showed a small recurrence.

• Brand Name: VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7149482
• MDR Text Key: 95872399
• Report Number: 2210968-2017-71992
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/01/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 3