COVIDIEN, FORMERLY US SURGICAL A DIVISON BIOSYN¿ MONOFILAMENT ABSORBABLE SUTURE 4-0 1.5 METRIC 18"; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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Model Number SM5627 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problems
Abscess (1690); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer reference number: (b)(4).Additional information was requested however only limited details were received and all available information at the time of this report, has been included.Should additional information be provided, the file will be updated.Additional information: the lot information is reported to be not available it has been reported that no product will be returned for evaluation.Only the gender of the patient (female) could be provided.
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Event Description
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According to the reporter, a few weeks after a procedure on the wrist the patient presented with negative reactivity to the suture in the wrist and hand region.An abscess had formed at the site of the suture and as a result the doctor removed the suture.The current patient status is fine and there were no long term affects.
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Search Alerts/Recalls
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