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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 3X3 -200 SURGICAL PATTIES

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INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 3X3 -200 SURGICAL PATTIES Back to Search Results
Catalog Number 801409
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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
A facility reported an incorrect count in the packaging of surgical patties. Staff reportedly opened the surgical patties 3¿ x 3¿ and noted an extra ¿one blank white sheet¿ in addition to the labeled 10 available in the package. The package was reportedly taken outside the room before the planned operation. The product was not in contact with the patient and the event led to surgical delay (unknown for how long). No patient injuries were reported.
 
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Brand NameSURG PAT XRAY 3X3 -200
Type of DeviceSURGICAL PATTIES
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA 02048
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA 02048
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key10654424
MDR Text Key210595637
Report Number3014334038-2020-00061
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,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number801409
Device Lot NumberJ4044G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/25/2019
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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