MAUDE Adverse Event Report: MEDLINE INDUSTRIES C-SECTION PACK; CESAREAN SECTION TRAY

Model Number DYNJ5517F

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

C-section pack contains four packs of 5 lap sponges.Our kits contain a total of 20 lap sponges.One of the four lap sponge packs (# (b)(4)), only had four lap sponges (vs.Five sponges).

Event Description

C-section pack contains four packs of 5 lap sponges.Our kits contain a total of 20 lap sponges.One of the four lap sponge packs (# (b)(4)), only had four lap sponges (vs.Five sponges).

• Brand Name: C-SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline pl.; mundelein IL 60060
• MDR Report Key: 13534226
• MDR Text Key: 285622598
• Report Number: 13534226
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2022,12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ5517F
• Device Catalogue Number: DYNJ5517F
• Device Lot Number: 21JBL834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2022
• Date Report to Manufacturer: 02/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Female