MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT; VAGINAL MESH

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Tissue Damage (2104); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient allegedly experienced mesh exposure.Action taken: patient requested local excision.Per additional information received via email on 12 december 2019 from ibc representative, "based on consensus statements from the ics and the international urogynecological association (iuga), the term ¿exposure¿ will be used to describe vaginal mesh visualized through separated vaginal epithelium and ¿extrusion¿ will refer to the passage of mesh out of a body structure or tissue, such as the presence of mesh within the bladder or urethra.".

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause of the reported event could be that the physician was not properly trained or skipped steps of using blunt instrument due to which not enough tension was put on the sling, resulting in exposure of mesh and requirement of additional procedure.The lot number is unknown therefore the device history record could not be reviewed.A labeling review cannot be performed since the product catalog number is unknown.H11: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.H3 other text : the device was not returned.

Event Description

It was reported that the patient allegedly experienced mesh exposure.Action taken: patient requested local excision per additional information received via email n (b)(6)2019 from ibc representative, "based on consensus statements from the ics and the international urogynecological association (iuga), the term ¿exposure¿ will be used to describe vaginal mesh visualized through separated vaginal epithelium and ¿extrusion¿ will refer to the passage of mesh out of a body structure or tissue, such as the presence of mesh within the bladder or urethra.".

• Brand Name: UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT
• Type of Device: VAGINAL MESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9530459
• MDR Text Key: 178591766
• Report Number: 1018233-2019-08315
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K093747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other