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

Catalog Number	5954600
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that they inadvertently implanted an expired ventralight st mesh into the patient.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error with no malfunction of the device.As reported the surgeon has no clinical concerns for the patient at this time.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2018.Not returned, remains implanted.
Event or Problem Description
As reported, the patient was implanted with a ventralight st mesh which was 2 months beyond the labeled expiration date.The surgeon noted that the packaging was intact and product appeared to function as intended.The surgeon chose to leave the mesh implanted in the patient and has no clinical concerns at this time.
Additional Manufacturer Narrative
The user facility reported that they inadvertently implanted an expired ventralight st mesh into the patient.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error with no malfunction of the device.As reported the surgeon has no clinical concerns for the patient at this time.To date, this is the only reported complaint for this manufacturing lot of 63 units released for distribution in march 2018.Addendum: h11: this is an addendum to the initial emdr submitted on 13-jul-2020.This supplemental emdr was submitted to correct the previously reported manufacturing lot quantity in the h10 field.Correction to lot quantity: to date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2018.Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, the patient was implanted with a ventralight st mesh which was 2 months beyond the labeled expiration date.The surgeon noted that the packaging was intact and product appeared to function as intended.The surgeon chose to leave the mesh implanted in the patient and has no clinical concerns at this time.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10267904
• Report Number: 1213643-2020-06580
• Device Sequence Number: 16895200
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 5954600
• Device Lot Number: HUCN1772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1