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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X1 -200 SURGICAL PATTIES

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RAYNHAM SURG PAT XRAY 1/2X1 -200 SURGICAL PATTIES Back to Search Results
Catalog Number 801402
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
Event Type  malfunction  
Manufacturer Narrative
The pattie/strip was returned for evaluation. Device identifier: (b)(6). Device history record (dhr) - there is no indication that the production process may have contributed to this complaint. All test results passed procedural specifications. Failure analysis - the pattie/strip unit was inspected using the unaided eye and no anomalies were observed, the packaging met requirements per the procedures. The returned unit was found to work as intended, and met all acceptance criteria. The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
 
Event Description
A facility reported that the thickness of the sealing part with sterilization pouch was not uniform before the procedure. A new one was used, and the procedure was completed. There was no surgical delay and there was no adverse consequence to the patient. No further information was provided by hospital.
 
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Brand NameSURG PAT XRAY 1/2X1 -200
Type of DeviceSURGICAL PATTIES
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA 02767
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key10623997
MDR Text Key213922051
Report Number3014334038-2020-00055
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 foreign
Reporter Occupation
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number801402
Device Lot NumberJ09D39
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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