MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number	1151520
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.When the investigation has been completed, a supplemental emdr will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2020, a surgeon had opened a piece of xenmatrix ab and soaked in nss (normal sterile saline) for five (5) minutes.After it was removed, it was noted that the orange coating was peeling off in large quantities, onto the surgeon¿s gloves, etc.The surgeon did not want the large sloughing of coating to cause damage to the patient and decided to not implant the piece in question.As reported, there was no injury or impact to the patient.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.When the investigation has been completed, a supplemental emdr will be submitted.Addendum: this is an addendum to the initial emdr submitted on (b)(6) 2020.This supplemental emdr was submitted to document the results of sample evaluation.As reported, in preparation to implant the xenmatrix ab, the user hydrated the unit in accordance with the instructions for use.The returned sample was received with little to no ab coating, and in a visual condition consistent with a device that had been hydrated, with no deficiency noted related to the substrate xenmatrix device.The manufacturing process includes coating integrity testing, utilizing a method that simulates the product handling during preparation (hydration) and deployment of the device.No discrepancies were found during a lot manufacturing review that focused on the potential manufacturing activities that could cause the reported event.With the available information, sample evaluation and investigation activities, the root cause for the reported issue could not be determined.Note: section a through f - the information provided by bard 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 bard.
Event or Problem Description
It was reported that on (b)(6) 2020, a surgeon had opened a piece of xenmatrix ab and soaked in nss (normal sterile saline) for five (5) minutes.After it was removed, it was noted that the orange coating was peeling off in large quantities, onto the surgeon¿s gloves, etc.The surgeon did not want the large sloughing of coating to cause damage to the patient and decided to not implant the piece in question.As reported, there was no injury or impact to the patient.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10049301
• Report Number: 1213643-2020-04663
• Device Sequence Number: 11472003
• Product Code: PIJ
• UDI-Device Identifier: 00801741074240
• UDI-Public: (01)00801741074240
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• 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): 06/26/2020

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: 01/28/2022
• Device Catalogue Number: 1151520
• Device Lot Number: HUDX2609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1