LiNA Skin Hook™ SH-110Recalls & reported problems
Lina Medical ApS · SMALL SHARP, dual pack · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708265000401), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON JANUARY 24, 2025, LINA MEDICAL RECEIVED A NOTIFICATION FROM THE FDA INFORMING THAT THEY HAD RECEIVED A REPORT CONCERNING OUR DEVICE THROUGH THE MEDWATCH PROGRAM. THE DESCRIPTION OF THE EVENT IS AS FOLLOWS: "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." LINA MEDICAL INFORMED THE U.S. DISTRIBUTOR ABOUT THE EVENT AND REQUESTED MORE DETAILED INFORMATION. THE FOLLOWING DETAILS WERE PROVIDED BY THE LINA MEDICAL U.S. (DISTRIBUTOR): "LINA SHARP SKIN HOOKS USED WITH LINA SELF-RETAINING RETRACTOR FRAME FOR A POSTERIOR COLPORRHAPHY. SKIN HOOKS CAUSED BILATERAL VAGINAL LACERATIONS FROM THE HOOKS. THE RETRACTOR WAS REMOVED AND LACERATIONS WERE REPAIRED USING SUTURE. NO FURTHER COMPLICATIONS WERE NOTED." THE DISTRIBUTOR PROVIDED WITH A PROBABLE LOT NUMBER.
Patient problems: Laceration(s)
MAUDE report 21432821 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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