MAUDE Adverse Event Report: COOPERSURGICAL, INC. FETAL PILLOW; BIRTHING/DELIVERY KIT

Model Number	FP-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: literature:journal article citation: mumtaz h, magro m, kunal rathod k.Two cases of posterior uterine rupture after foetal pillow use; do we need to think twice about using the foetal pillow j gynecol clin obstet reprod med.2023;1 3:90-5.G2: foreign: united kingdom.Complaint generated from journal arcticle.The location of the device is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was published in the journal of gynecology, clinical obstetrics and reproductive medicine, that the patient made an informed decision and opted for vaginal birth after a caesarean section.During active pushing ctg concerns arose, so, a decision was made to deliver baby in theatre via caesarean section.Fetal pillow was placed in the vagina as per the manufacturer's guidelines.A 10cm vertical full-thickness uterine posterior wall rupture was noted on the left side medial to the broad ligament.Surgical repair of the posterior uterine wall was done.A live male infant weighing 2865gm was delivered in good condition.The patient's immediate and long-term recovery was uneventful.1216677-2023-00130 fp-010 fetal pillow.
Event or Problem Description
Upon review, it was found that the submission name is incorrect.This report is to correct the submission name.1216677-2023-00164 fp-010 fetal pillow 2023-09-0000164.
Additional Manufacturer Narrative
Upon review, it was found that the submission name is incorrect.This report is to correct the submission name.1216677-2023-00164 fp-010 fetal pillow 2023-09-0000164.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Distribution history: the complaint product was purchased from vitalcare trading limited.Manufacturing record review: manufacturing record review not applicable to this product.Incoming inspection review: a review of the incoming inspection record could not be performed because the complaint product lot/serial number was not provided.Should the complaint product lot/serial number be provided going forward, the incoming inspection report will be reviewed, and this complaint amended accordingly.Service history record : service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Patient injury has been reported during c-sections utilizing the fetal pillow, for which all complaints resulted in an mdr number.However, these complaints could not be confirmed since none of the complaint products were returned to csi for evaluation.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation : evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause : root cause not applicable as the complaint condition was not confirmed.Evaluation of the publications was completed by a health care practitioner.Hcp's finding was: based on my review of the mumtaz publication, as well as the coopersurgical psur, and considering the baseline risk of uterine rupture (without use of the fetal pillow), i do not believe there is an indication of increased risk of uterine rupture from use of the fetal pillow.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: FETAL PILLOW
• Common Device Name: BIRTHING/DELIVERY KIT
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 17802585
• Report Number: 1216677-2023-00164
• Device Sequence Number: 12501098
• Product Code: PWB
• UDI-Device Identifier: 05060388740009
• UDI-Public: (01)05060388740009
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: FP-010
• Device Catalogue Number: FP-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2023
• Supplement Date Received by Manufacturer: 09/09/2023; 11/10/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 09/22/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian