MAUDE Adverse Event Report: PROGRESSIVE MEDICAL, INC. PMI SOLOBAG INTRODUCTER POLYMER SPECIMEN BAG; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number PPI0280

Device Problem Material Rupture (1546)

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

Event Date 04/07/2021

Event Type  Injury  

Event Description

Pmi solobag ruptured when pulling ovarian cyst wall through abdomen causing cyst to fall back into field.Fda safety report id# (b)(4).

• Brand Name: PMI SOLOBAG INTRODUCTER POLYMER SPECIMEN BAG
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): PROGRESSIVE MEDICAL, INC. ; fenton MO 63026
• MDR Report Key: 11693053
• MDR Text Key: 246508971
• Report Number: MW5100854
• Device Sequence Number: 1
• Product Code: GCJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/16/2021

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 Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: PPI0280
• Device Lot Number: 21PPI028010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 81