MAUDE Adverse Event Report: DERMA SCIENCES, INC. LAPAROTOMY SPONGES, XRAY DET - 18" X 18", 4 PLY

Catalog Number 1212

Device Problem Material Disintegration (1177)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the laparotomy sponges (unwashed) are leaving fibers behind in the patient's abdomen resulting in abdomen needing to be washed multiple times prior to closing.The event led to surgical delay, however, it is unknown for how long.

Event Description

N/a.

Manufacturer Narrative

The sponge laparotomy was not returned for evaluation.Device history record (dhr) - there is no nc or deviation at the time of release.Since this item is unwashed, the fiber could not be removed via washing and drying process and minimal lint will stay on the products.Root cause is that the product family is an unwashed lap sponge.The unwashed lap sponges have a greater tendency to lint and it's natural of the product since there was no bleaching or washing process to remove the lint.

• Brand Name: LAPAROTOMY SPONGES, XRAY DET - 18" X 18", 4 PLY
• Type of Device: LAPAROTOMY SPONGE
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• MDR Report Key: 12351294
• MDR Text Key: 267672362
• Report Number: 9680091-2021-00011
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1