MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA PLUS

Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Arthralgia (2355)

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 had two slings implanted on (b)(6) 2008 and has had mesh erosion, chronic pain, inflammation, infection, and joint pain.Removal was scheduled for 2020.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause of the reported event could be that the patient is not assessed for suitability and is not a good candidate for this surgery, either because physician does not know to check a patient for suitability, or physician does not know what makes a patient suitable for procedure.The lot number is unknown; therefore, the device history record could not be reviewed.Since the product catalog number is unknown, a labeling review cannot be performed.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 had two slings implanted on (b)(6) 2008 and has had mesh erosion, chronic pain, inflammation, infection, and joint pain.Removal is scheduled for 2020.

• Brand Name: AVAULTA PLUS
• Type of Device: AVAULTA PLUS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9819271
• MDR Text Key: 183088312
• Report Number: 1018233-2020-01737
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other