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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1X3 -200; SURGICAL PATTIES
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RAYNHAM SURG PAT XRAY 1X3 -200; SURGICAL PATTIES Back to Search Results
Catalog Number 801408
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2019
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that on (b)(6) 2019, the surg pat xray 1x3 -200 presented foreign matter.This complaint was received directly from (b)(6), therefore no further information can be obtained.
 
Manufacturer Narrative
Udi (b)(4).The complaint sample was not returned to codman, therefore, an evaluation of the device could not be performed.Device history records (dhrs) were reviewed and no anomalies were found.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.
 
Event Description
N/a.
 
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Brand Name
SURG PAT XRAY 1X3 -200
Type of Device
SURGICAL PATTIES
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key8812194
MDR Text Key151748577
Report Number1226348-2019-00281
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number801408
Was Device Available for Evaluation? No
Date Manufacturer Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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