MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PATXRAY 1/2X1/2-200; SURGICAL PATTIES

Catalog Number 801400

Device Problem Material Separation (1562)

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

Event Type  Injury  

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 a cotton of a pattie remained in the patient and its undergoing another surgery after the closure due to the failure of the surgical patties.The wire detached from the cotonoid.They don¿t know when the string broke, probably during the removal because the cotton was between the skin and the bone.

Event Description

N/a.

Manufacturer Narrative

Patties were not returned; however, photos were provided by the customer.Dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - photos were received in lieu of product to return.The photo provided is just of the string which broke and not of the pattie which was retrieved, and based on this photo, it is not possible to confirm if the breakage occurred a few centimeters from the attachment point was was reported by the customer.Therefore, the complaint cannot be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was not received for analysis and the investigation could not confirm the complaint through the use of the provided photo due to the picture lacking photo evidence of what was reported to have occurred.

• Brand Name: SURG PATXRAY 1/2X1/2-200
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 12250442
• MDR Text Key: 264266992
• Report Number: 3014334038-2021-00149
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 801400
• Device Lot Number: J9002D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1