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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM BULK SURG PAT 1/2 X 1/2; OEM PATTIES & STRIPS
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RAYNHAM BULK SURG PAT 1/2 X 1/2; OEM PATTIES & STRIPS Back to Search Results
Catalog Number 245404
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the strings of a surgical pattie aren¿t on all the way, some barely attached.No patient injury reported.
 
Manufacturer Narrative
Surgical pattie was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
Event Description
N/a.
 
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Brand Name
BULK SURG PAT 1/2 X 1/2
Type of Device
OEM PATTIES & STRIPS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA
MDR Report Key12148174
MDR Text Key264283978
Report Number3014334038-2021-00135
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 company representative,user f
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number245404
Device Lot Number5135980
Was Device Available for Evaluation? No
Date Manufacturer Received07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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