ACUFEX SURETAC II W/SPIKES, STERILE 014567

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1997-04-11 for ACUFEX SURETAC II W/SPIKES, STERILE 014567 manufactured by Smith & Nephew Endoscopy, Inc..

Event Text Entries

[55529] Pt reported to have frozen shoulder 6-8 weeks following shoulder surgery. A second arthroscopic procedure was performed to debride and manipulate shoulder. Pt has recovered well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219602-1997-00029
MDR Report Key84654
Report Source05,07
Date Received1997-04-11
Date Mfgr Received1997-03-17
Date Added to Maude1997-04-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACUFEX SURETAC II W/SPIKES, STERILE
Generic NameBIOABSORBABLE FIXATION DEVICE
Product CodeMBJ
Date Received1997-04-11
Model NumberNA
Catalog Number014567
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrN
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key83906
ManufacturerSMITH & NEPHEW ENDOSCOPY, INC.
Manufacturer Address130 FORBES BLVD. MANSFIELD MA 02048 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-04-11

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