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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM BULK SURG STRIP 1/2 X 6; OEM PATTIES & STRIPS

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RAYNHAM BULK SURG STRIP 1/2 X 6; OEM PATTIES & STRIPS Back to Search Results
Catalog Number 245432
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
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 tone of the cottonoids is not on a string.
 
Manufacturer Narrative
It was originally reported that the lot number was hz504.However, the distributor has informed us that the lot number provided is not accurate and there it no further information available making this an unknown lot.Complaint sample was received and damage to pattie confirmed.Evaluation could not be performed as provided lot number did not match a ½¿ x ½¿ product code.The lot number is required to conduct an investigation.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint lot information becomes available, this complaint will be reopened, and the respective evaluation performed.
 
Event Description
N/a.
 
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Brand Name
BULK SURG STRIP 1/2 X 6
Type of Device
OEM PATTIES & STRIPS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key8491492
MDR Text Key141216879
Report Number1226348-2019-00058
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 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number245432
Device Lot NumberHZ5004
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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