MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1/2 X 3; PATTIE, COTTONOID

Catalog Number 80-1407

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Udi -- (b)(4).Attempts are being made to obtain additional information.Upon completion of the investigation, follow-up report will be submitted.

Event Description

As reported by the affiliate, an unopened pack of surgical patties contained a contaminant.There were no reports of delay or patient harm.

Manufacturer Narrative

Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: SURG PAT XRAY 1/2 X 3
• Type of Device: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8143543
• MDR Text Key: 129890081
• Report Number: 1226348-2018-10853
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

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: Other
• Device Catalogue Number: 80-1407
• Device Lot Number: HK7284
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1