MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN (R) URETHRAL SUPPORT SYSTEM; UNKNOWN ALIGN MESH

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

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 alleged an unknown align mesh caused pain.Patient underwent total removal of mesh.

Event Description

It was reported that the patient alleged an unknown align mesh caused pain.Per cir attached, patient underwent total removal of the mesh.

Manufacturer Narrative

The device was not 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.The labeling review could not 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.

• Brand Name: ALIGN (R) URETHRAL SUPPORT SYSTEM
• Type of Device: UNKNOWN ALIGN MESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9856698
• MDR Text Key: 188337210
• Report Number: 1018233-2020-01968
• 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: 04/24/2020

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: 02/27/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention