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Catalog Number 0117080 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Discomfort (2330)
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Event Date 11/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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As reported, 2 days post-implant of the bard/davol perfix plug light, the patient experienced foreign body sensation.It was reported that the patient continues postoperative anti-inflammatory treatment.Additional information has been requested.Based on the available information, no conclusion can be made.No lot number was provided; therefore, a review of the manufacturing records is not possible.
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Event Description
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As per nmpa (china fda): as reported, the patient was hospitalized for a right indirect inguinal hernia repair and was implanted with a bard/davol perfix light plug on (b)(6) 2021.It was reported that on (b)(6) 2021, the patient felt that the foreign body sensation at the patch implantation site and also the flexion and movement of the right lower limb were aggravated, there was no redness, swelling and pain, and the external dressing of the incision was dry and there was no exudation.It was also reported that the patient continues postoperative anti-inflammatory treatment.
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Search Alerts/Recalls
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