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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AJUST¿ ADJUSTABLE SINGLE INCISION SLING (5-PACK); AJUST® ADJUSTABLE SINGLE-INCISION SLING
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C.R. BARD, INC. (COVINGTON) -1018233 AJUST¿ ADJUSTABLE SINGLE INCISION SLING (5-PACK); AJUST® ADJUSTABLE SINGLE-INCISION SLING Back to Search Results
Catalog Number BRD705SI
Device Problems Loose or Intermittent Connection (1371); Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
Patient Problems Erosion (1750); Intermenstrual Bleeding (2665)
Event Date 03/26/2019
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 ajust was implanted and subsequently re-operated two times due to the exposition of the sling.In the second surgery, the biological mesh was inserted in connection with the reconstruction.The patient mentioned that she had spot bleedings when she had physical activity as well as intercourse, where the partner also noticed stitches.On examination, the exposed sling with the anchor from the tvt ajust were found loose 2 cm in the vagina.The tip was cut off and the patient was informed that the sling material should be removed.
 
Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: the ajust® adjustable single-incision sling system is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.Contraindications: the ajust® sling system is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field.Warnings: the implant procedure and the instrumentation associated with the surgical placement of the ajust® sling system carry an inherent risk of infection and bleeding, as do similar urological procedures.The use of surgical staples, clips, screws, or other non-suture attachment mechanisms not supplied with the ajust® sling system can damage the implant.After use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Patient code: 2564.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.The device was not returned.
 
Event Description
It was reported that the ajust had been re-operated on twice since implantation due to the exposition of the sling.In the second surgery, the biological mesh was inserted in connection with the reconstruction.The patient allegedly experienced spot bleedings during physical activity and during intercourse, where her partner also noticed stitches.On examination, it was found that two (2) cm of the sling with the anchor from the tvt ajust was exposed in the vagina.The tip was cut off and the patient was informed that the sling material should be removed.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported event could be incorrect anchor placement by physician due to which the anchor does not remain below the skin surface sufficiently to prevent the patient from feeling the anchor, resulting in patient discomfort / dissatisfaction and causing unnecessary trauma of tissue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿the ajust® adjustable single-incision sling system is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.Contraindications the ajust® sling system is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field.Warnings the implant procedure and the instrumentation associated with the surgical placement of the ajust® sling system carry an inherent risk of infection and bleeding, as do similar urological procedures.The use of surgical staples, clips, screws, or other non-suture attachment mechanisms not supplied with the ajust® sling system can damage the implant.After use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.".
 
Event Description
It was reported that the ajust had been re-operated on twice since implantation due to the exposition of the sling.In the second surgery, the biological mesh was inserted in connection with the reconstruction.The patient allegedly experienced spot bleedings during physical activity and during intercourse, where her partner also noticed stitches.On examination, it was found that two (2) cm of the sling with the anchor from the tvt ajust was exposed in the vagina.The tip was cut off and the patient was informed that the sling material should be removed.
 
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Brand Name
AJUST¿ ADJUSTABLE SINGLE INCISION SLING (5-PACK)
Type of Device
AJUST® ADJUSTABLE SINGLE-INCISION SLING
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8575400
MDR Text Key143935399
Report Number1018233-2019-02284
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
PMA/PMN Number
K092607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2011
Device Catalogue NumberBRD705SI
Device Lot NumberHUTE0896
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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