Model Number N/A |
Device Problems
Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)
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Patient Problem
Fall (1848)
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Event Date 07/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Event description as received on (b)(6) 2016: "faxed paper work from the pap group stating it started on the right side first injected 2cc of orthovisc batch number n150087a, 01/18 expiration with 2cc of 1% lidocaine without epinephrine or preservative and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected without difficulty.I did get verbal consent and the patient identified the right side as the correct side.I then went to the left side third injection 2cc of orthovisc batch number n150087a, 01/18 expiration and with 2cc of 1% lidocaine without epinephrine or preservatives and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected with following ethyl chloride anesthesia into the glenohumeral joint without difficulty.This is the third injection in her left shoulder so we did two injections one in the right one in the left both third injections.She tolerated the injections sent her on the way talked about surgery.She did fall.She got x-rays at (b)(6) two views right shoulder.She has pretty severe medialization multiple vascular clips consisting with lymph node dissection and a small chip medially inferior glenoid.I do believe that her humerous is impinging on her glenoid inferiorly because she has a medial wear and probably cracked that.Otherwise, i did not see any fracture that were obvious my thoughts even doing a shoulder replacement on her.It is going to be a challenge because she has such medialization.She will need a bone increased offset implant.I will see her back as needed.".
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Manufacturer Narrative
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The lot met the specifications for release.This report was originally filed on 03feb2017 on the test server.The account was approved and moved to the production server on 7august2017.I was informed to resubmit all previous files to the production server.Production account approval help desk ticket # (b)(4).Notification of moving files to production account help desk ticket # (b)(4).
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Event Description
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Event description as received on (b)(6) 2016: "faxed paper work from the pap group stating it started on the right side first injected 2cc of orthovisc batch number n150087a, 01/18 expiration with 2cc of 1% lidocaine without epinephrine or preservative and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected without difficulty.I did get verbal consent and the patient identified the right side as the correct side.I then went to the left side third injection 2cc of orthovisc batch number n150087a, 01/18 expiration and with 2cc of 1% lidocaine without epinephrine or preservatives and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected with following ethyl chloride anesthesia into the glenohumeral joint without difficulty.This is the third injection in her left shoulder so we did two injections one in the right one in the left both third injections.She tolerated the injections sent her on the way talked about surgery.She did fall.She got x-rays at (b)(6) two views right shoulder.She has pretty severe medialization multiple vascular clips consisting with lymph node dissection and a small chip medially inferior glenoid.I do believe that her humorous is impinging on her glenoid inferiorly because she has a medial wear and probably cracked that.Otherwise, i did not see any fracture that were obvious my thoughts even doing a shoulder replacement on her.It is going to be a challenge because she has such medialization.She will need a bone increased offset implant.I will see her back as needed.".
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Search Alerts/Recalls
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