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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM BULK SURG PAT 1/2 X 3; OEM PATTIES & STRIPS
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RAYNHAM BULK SURG PAT 1/2 X 3; OEM PATTIES & STRIPS Back to Search Results
Catalog Number 245411
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2019
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
It was reported that the neuro sponge left fibers behind in the patient.The sample is not available for evaluation.
 
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
BULK SURG PAT 1/2 X 3
Type of Device
OEM PATTIES & STRIPS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key8660754
MDR Text Key151035582
Report Number1226348-2019-00175
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
Type of Report Initial,Followup
Report Date 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number245411
Device Lot NumberJ19G32
Was Device Available for Evaluation? No
Date Manufacturer Received08/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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