FDA.reportPublic FDA data

MAUDE MDR 5925040

MDR report key
5925040
Report number
2916714-2016-00715
Event key
0
Event type
3
Date of event
2016-07-28
Date received
2016-09-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. NICOLE BROYLES
Address
615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
Phone
314-314-3145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MONOMAX VIOLET 0 (3,5) 150CM HR26 (M)SUTURESB.BRAUN SURGICAL SANWJB0041441B0041441116015V004Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-0201. O

Event Narratives#

N

Patient 1

(B)(4). MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 7 UNOPENED AND 1 OPEN POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED OF THIS CODE BATCH, THERE ARE NO UNITS IN STOCK. THE OPEN SAMPLE RECEIVED HAD ONLY THE SECOND PACK OPENED, BUT IT WAS NOT ATTACHED/GLUED TO THE FIRST PACK. HOWEVER, THERE ARE SIGNS THAT THE FIRST AND SECOND PACKS WERE SEALED TOGETHER. THE 7 UNOPENED POUCHES RECEIVED HAVE BEEN OPENED AND NONE OF THEM HAD THE ALUMINUM POUCH (FIRST PACK) SEALED/STUCK TO THE FOIL (SECOND PACK). ALL PACKS HAVE BEEN OPENED CORRECTLY. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLS THE OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. THIS IS CONSIDERED AN ISOLATED UNIT. NOTE OF THIS INCIDENCE IS TAKEN IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO THE INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

D

Patient 1

COUNTRY OF COMPLAINT: (B)(6). IT IS REPORTED THAT THE INNER FOIL IS SEALED TO THE OUTER FOIL AND STERILE WITHDRAWAL FROM POUCH CAN NOT BE GUARANTEED.