MAUDE Adverse Event Report: COOPERSURGICAL, INC. SOS; FETAL HEAD ELEVATOR

Model Number	FP-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse event was reported in the c-section delivery where the fetal pillow was used.The patient had severe uterine extensions that needed to be repaired.According to the reporter, "to my knowledge there was not anything wrong with the fetal pillow, it's use is supposed to reduce uterine extensions and dr cheng reported that the "worst extensions they've seen in a while"." there was not blame on the pillow for the extensions as the exact reasons for them appear to be unknown, but what is known is that the fetal pillow was used to assist in delivery.To my knowledge the integrity of the fetal pillow was intact.Any patient injury or impact to the gamete or embryo? no medical or procedural intervention? no.Fp-010 fetal pillow 2023-08-0000351.
Additional Manufacturer Narrative
Customer has indicated that the product will not be returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
H4: mfr date unknown.Distribution history: the complaint product was purchased from vitalcare trading limited by csi.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 number was not provided.Should the complaint product lot 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 (b)(4) similar reported complaint condition.However, this complaint could not be confirmed as the product was not returned to csi.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 is not being returned.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product is not being returned.The case file was evaluated by dr.Robert auerbach and this is his summary: i do not see any malfunction of the fetal pillow, need for further investigation or reporting.As noted previously, fetal pillow is designed to ease delivery in patients with full dilation arrest of labor.While some studies show a reduction in laceration occurrence, that is not universal.Midline lacerations, like in this case, are typically much easier to repair than lateral lacerations and in this case the repair appears straightforward.While the blood-loss was higher than typical in a c-s, it is more likely related to the atony that was treated with multiple medications.Note - under normal circumstances only one uterotonic agent is used.Root cause : root cause not applicable as the complaint condition was not confirmed.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: SOS
• Common Device Name: FETAL HEAD ELEVATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 17605773
• Report Number: 1216677-2023-00119
• Device Sequence Number: 12302499
• Product Code: PWB
• UDI-Device Identifier: 05060388740009
• UDI-Public: (01)05060388740009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FP-010
• Device Catalogue Number: FP-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/26/2023
• 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: Other
• Patient Sex: Unknown