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Model Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Fever (1858); Nausea (1970); Pain (1994); Chills (2191); Dizziness (2194)
Event Date 04/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Home nurse: (b)(6) 2021 [po # 3] nurse: opov withdrawal, no flow. Instructions that he can shower without direct jet on the surgical site and dry well. (b)(6) 2021 [po # 6] physio: mild heat right hip (inflammatory type) no discharge, no redness (b)(6) 2021 [po # 12] nurse: adhesive withdrawal. Dried blood crusted along the wound. No redness, no discharge, no sign of infection. Adhesion of wound edges (b)(6) 2021 [po # 15] physio, no redness, no discharge, no dehiscence. Moderate adhesion all along the wound. (b)(6) 2021 [po # 19] telephone call nurse r / a adhesive withdrawal: wound edges open upper extremity with ventral fatty folds. Redness + edema + discharge for 3 days. Transfer to routine care in order to assess. (b)(6) 2021 (revision po # 14) nurse: removal of staples (according to surgical report: points to close), wound dehiscence in superior. (b)(6) 2021 wound healed. Post revision microbiology monitoring: (b)(6) 2021: ancef j9, wound closed and threads in place. (b)(6) 2021: ancef j16, rifampin j7, persistence of flow from the upper portion of the wound to be monitored. (b)(6) 2021: ancef j23 rifampin j14, persistence of upper and lower sero-blood flow. No redness. (b)(6) 2021: ancef j30, rifampin j21, persistent flow but point found and removed. (b)(6) 2021: ancef j37, rifampin j28, good development, flow stopped. (b)(6) 2021: ancef iv ceased, addition of levofloxacin + rifampin po continued. (b)(6) 2021: antiobio ceased. Post-revision ortho follow-up: (b)(6) 2021 see again in 12 months. According to the various notes read, the user seems to respect the instructions given in connection with hygiene care and asepsis around the care of his wound and the use of his iv. Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Was prineo and/or stratafix used during the revision surgery? if so please provide which products were used and on which tissue layer. Did the wound dehisce after the initial procedure? did the wound dehisce after the revision surgery? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what is the physician¿s opinion as to the etiology of or contributing factors to this event? surgeon¿s name? lot numbers? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? how much and what type of drainage is present in this wound? please describe how was the adhesive was applied? on what tissue was the suture used/location of suture placement? what tissue dehisced? what was the tissue condition (normal, thin, calcified, fragile, diseased)? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings. Please describe the appearance of the suture during the second procedure. Were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? no product is available for return. Note: events reported on mw# 2210968-2021-09479, mw# 2210968-2021-09480.
Event Description
It was reported a patient underwent a right anterior total (b)(6) on (b)(6) 2021 and topical (b)(6) was used. On (b)(6) /2021 (post op day # 24) patient went to emergency visit. Patient had onset redness and pain when walking, temperature x 24 hours, chills, nausea, dizziness. Superficial pus: staph aureus in the wound, with abscess, wound dehiscence at the upper point since surgery on (b)(6) 2021 patient was hospitalized. Revision surgery: debridement / washing and change of liner and femoral head. Closure with staples / mepilex. Follow-up with microbio and aaiv [ancef iv then addition of rifampin po]. Additional information has been requested.
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Manufacturer (Section D)
1000 route 202
raritan NJ 08869
MDR Report Key12607805
MDR Text Key283607434
Report Number2210968-2021-09478
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/11/2021 Patient Sequence Number: 1