MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954610
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Edema (1820); Urticaria (2278); Reaction (2414)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided to date, no conclusion can be made regarding a correlation between the patient's postoperative course and the bd/bard device used to treat the patient.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Additional information has been requested including the date of implant and product lot number.The instructions-for-use (ifu) supplied with the device identifies allergic reaction as a possible complication.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that following implant of a ventralight st, the patient had adverse effects like allergy type edema of lips, neck and was treated with solumedrol (corticosteroid) by the surgeon.It had evolved and turned into hives on upper and lower limbs.There was no increase in temperature and blood culture was negative.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10553445
• Report Number: 1213643-2020-20002
• Device Sequence Number: 2842817
• Product Code: FTL
• UDI-Device Identifier: 00801741031649
• UDI-Public: (01)00801741031649
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 5954610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention