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

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Urinary Tract Infection (2120)

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 experienced ongoing medical problems including a urinary tract infection, pain, bleeding, and swelling of the abdomen.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "material selection" or " excessive tension" of the mesh.As no sample was returned it cannot be determined if the device met specifications or if there is a relationship between the reported event and the device.Based on the reported event, it appears that the device was used for treatment.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not 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.

Event Description

It was reported that the patient experienced ongoing medical problems including a urinary tract infection, pain, bleeding, and swelling of the abdomen.

• Brand Name: UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT
• Type of Device: MESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10010031
• MDR Text Key: 189494801
• Report Number: 1018233-2020-02927
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other