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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMENS HEALTH MESH PRODUCT
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMENS HEALTH MESH PRODUCT Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Fragmentation (1261)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 02/05/2021
Event Type  malfunction  
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 metal end of the sacrospinous fixation suture retained within the pelvis but unfortunately detached.The patient was very concerned regarding reactions to the metal material that was in the pelvis.No medical intervention reported.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, g.H11: section a through f - the information provided by bd represents all 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 the metal end of the sacrospinous fixation suture retained within the pelvis but unfortunately detached.The patient was very concerned regarding the reaction to the metal material that was in the pelvis.No medical intervention reported.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 the metal end of the sacrospinous fixation suture retained within the pelvis but unfortunately detached.The patient was very concerned regarding reactions to the metal material that was in the pelvis.No medical intervention reported.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "inadequate design selection".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the women's health mesh ifus are found to be adequate based on past reviews.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
 
Event Description
It was reported that the metal end of the sacrospinous fixation suture retained within the pelvis but unfortunately detached.The patient was very concerned regarding reactions to the metal material that was in the pelvis.No medical intervention reported.
 
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Brand Name
UNKNOWN BMD WOMENS HEALTH MESH PRODUCT
Type of Device
UNKNOWN BMD WOMENS HEALTH MESH PRODUCT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11413277
MDR Text Key234696232
Report Number1018233-2021-00992
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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