MAUDE Adverse Event Report: CooperSurgical, Inc. SOS; FETAL PILLOW

Model Number	FP-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the australian tag that during a complicated birth, obstructed labour and fetal distress requiring manual fetal head disimpaction for planned emergency luscs, first attempted fetal pillow device and babe was born flat and suffered suspected subgaleal haemorrhage.Fetal pillow device recommended maximum inflation is 180cc and device found to have been inflated to 250cc.Baby required initial resuscitation and special care nursery for observation, subsequently baby discharged home.Unknown long term effects.1216677-2026-00076 fp-010 fetal pillow 2026-07-0000460.
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: SOS
• Common Device Name: FETAL PILLOW
• Manufacturer (Section D): CooperSurgical, Inc.; 95 corporate drive; trumbull CT 06611 -135
• Manufacturer (Section G): CooperSurgical, Inc.; 75 corporate drive; trumbull CT 06611 -135
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611--135 ; +1(475)265-1582
• MDR Report Key: 50117579
• Report Number: 1216677-2026-00076
• Device Sequence Number: 16015139
• Product Code: PWB
• UDI-Device Identifier: 05060388740009
• UDI-Public: (01)05060388740009
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K243799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Sex: Unknown