MAUDE Adverse Event Report: COOPERSURGICAL INC. FETAL PILLOW, BOX OF 6

Model Number FP-010

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hematoma (1884)

Event Date 09/10/2022

Event Type  Injury  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

When speaking with the physician about fetal pillow he stated he only used fetal pillow once with a severely impacted head.The baby developed a subdural hematoma.He said it was likely not related to the fetal pillow but wanted to know if it is possible if the use of it increased the risk.Fetal pillow box of 6 fp-010, (b)(4).

Manufacturer Narrative

Investigation : x-no sample returned.Analysis and findings : distribution history: the complaint product was purchased from vitalcare trading limited.Manufacturing record review: manufacturing record review is not applicable for this product.Incoming inspection review: a review of the device history record could not be performed because the lot/serial number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot/serial number be provided going forward, the device history record 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 did not show similar reported complaint conditions.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.Correction and/or corrective action : no further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Preventative action activity : coopersurgical will continue to monitor this complaint condition for trends.

Event Description

When speaking with the physician about fetal pillow he stated he only used fetal pillow once with a severely impacted head.The baby developed a subdural hematoma.He said it was likely not related to the fetal pillow but wanted to know if it is possible if the use of it increased the risk.1216677-2022-00272 fetal pillow box of 6 fp-010 (b)(4).

• Brand Name: FETAL PILLOW, BOX OF 6
• Type of Device: FETAL PILLOW
• 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 ; 4752651665
• MDR Report Key: 15562568
• MDR Text Key: 301351392
• Report Number: 1216677-2022-00272
• Device Sequence Number: 1
• Product Code: PWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN150053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FP-010
• Device Catalogue Number: FP-010
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention