inforMED
MalfunctionGAD

LINA SKIN HOOK SMALL SHARP DUAL PACK

Received Jan 7, 2025 · Event occurred Dec 30, 2024

Report MW5164432 · MDR key 21106115

Device

Generic name

Retractor

Manufacturer

Lina Medical Aps

Catalog number

SH-110

Patient

28 YR · Female

  • Laceration(s)
  • Laceration(s)

Narrative

Description of Event or Problem

LINA SHARP SKIN HOOKS USED WITH LINA SELF-RETAINING RETRACTOR FRAME FOR A POSTERIOR COLPORRHAPHY. SKIN HOOKS CAUSED LACERATIONS AT THE VAGINAL ENTRANCE WHICH WAS REPAIRED WITH SUTURE. NO FURTHER COMPLICATIONS NOTED. LINA SKIN HOOK SMALL SHARP DUAL PACK REF SH-110. UNABLE TO PROVIDE LOT NUMBER.