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

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Prolapse (2475); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2017

Event Type  Injury  

Event Description

It was reported that the implanted mesh detached abruptly from fixing.Customer went for additional gynecological consultations and it was confirmed that the pelvic mesh had failed causing internal injury to uterus and in addition had prolapsed again.Per additional information received on 20feb2024, it was reported that the bard mesh was implanted for a sacrohysteropexy procedure carried out by mr (b)(6) at (b)(6) hospital, (b)(6) on (b)(6) 2016.The patient underwent a lengthy operation on (b)(6) 2018 for mesh removal (explantation), vaginal hysterectomy, left saplingo oophorectomy with hysteropexy mesh removal, enterocele repair and pelvic floor repair with a modified mccall's culdoplasty at (b)(6) hospital as it was found to have detached from sutures and uterus was hanging lopsided.Also found that mesh adhered to peritoneal covering and to the right pelvic side wall, sacrum and anterior cervix.Bowel adhesions and adhered to bladder, uterine artery divided.Uterus was necrotic and left ovary had mature teratoma and foreign body giant cell reaction found on uterus.The patient experienced continual pain for years after and slow recovery and this was followed by a large rectocele on (b)(6) 2019, patient was waiting for surgery for repair and for a vaginal sacropinous fixation with sutures.

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.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Hence, the exact root cause could not be identified.A dhr could not be performed since no lot number was provided.The product family for this women¿s healthcare product is unknown; therefore, bard is unable to determine the associated labeling review.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 implanted mesh detached abruptly from fixing.Customer went for additional gynecological consultations and it was confirmed that the pelvic mesh had failed causing internal injury to uterus and in addition had prolapsed again.Per additional information received on (b)(6) 2024, it was reported that the bard mesh was implanted for a sacrohysteropexy procedure carried out by mr hillard at poole hospital, dorset on (b)(6) 2016.The patient underwent a lengthy operation on (b)(6) 2018 for mesh removal (explantation), vaginal hysterectomy, left saplingo oophorectomy with hysteropexy mesh removal, enterocele repair and pelvic floor repair with a modified mccall's culdoplasty at university college london hospital as it was found to have detached from sutures and uterus was hanging lopsided.Also found that mesh adhered to peritoneal covering and to the right pelvic side wall, sacrum and anterior cervix.Bowel adhesions and adhered to bladder, uterine artery divided.Uterus was necrotic and left ovary had mature teratoma and foreign body giant cell reaction found on uterus.The patient experienced continual pain for years after and slow recovery and this was followed by a large rectocele on (b)(6) 2019, patient was waiting for surgery for repair and for a vaginal sacropinous fixation with sutures.

• Brand Name: UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT
• Type of Device: UNKNOWN WOMEN HEALTH PRODUCT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18865933
• MDR Text Key: 337218279
• Report Number: 1018233-2024-01214
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 64 KG