Biogel® PI UltraTouch® 41180Recalls & reported problems
Mölnlycke Health Care AB · Biogel PI UltraTouch 8.0 x50 US · 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 07332551184834), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
CUSTOMER REPORTED PATIENT UNDER EVALUATION IN EMERGENCY DEPARTMENT (ED) UNDERWENT LEFT-SIDE CHEST TUBE PLACEMENT. NOTED UPON REMOVAL OF RESIDENT'S FINGER FROM CHEST, PORTION OF GLOVE TIP WAS MISSING - ESTIMATED AT 1X2CM (AT LARGEST). WOUND FLUSHED AND THEN CHEST FLUSHED WITH APPROXIMATELY 1L SALINE WITHOUT GLOVE PIECE BEING RETURNED. PATIENT INFORMED - NOTE IN CHART. UNKNOWN WHAT LED TO ISSUE - MIGHT HAVE BEEN CAUGHT ON INSTRUMENT IN CHEST AT TIME OF INSERTION. THE PATIENT WAS SEDATED WITH LOCAL ANESTHETIC DURING THE PROCEDURE (CHEST TUBE PLACEMENT). THERE WAS ADDITIONAL TIME SPENT IRRIGATING THE AREA TO LOOK FOR THE GLOVE FRAGMENT; HOWEVER, THE EXACT AMOUNT OF TIME WAS NOT DOCUMENTED. AS FAR AS FOLLOW UP TREATMENT, OPTIONS WERE SHARED WITH THE PATIENT AND FAMILY AT THE TIME OF DISCLOSURE. THE PATIENT CHOSE TO DO ONGOING MONITORING VS ADDITIONAL SURGICAL PROCEDURES. AT THIS TIME THERE IS NO INDICATION THE GLOVE WAS REMOVED FROM THE PATIENT. THEREFORE, DUE TO A LACK OF INFORMATION REGARDING MEDICAL INTERVENTION, THIS COMPLAINT HAS BEEN REASSESSED AND CLASSIFIED AS A SERIOUS EVENT ASSOCIATED WITH USE OF A MOLNLYCKE PRODUCT AND IS CONSIDERED REPORTABLE TO THE US FDA. WE WILL REASSESS
Patient problems: Foreign Body In Patient
MAUDE report 23429623 ↗
Other Surgeon's gloves devices
- GAMMEX 20685275Ansell Healthcare Product · Surgeon'S Gloves2 recalls0 reports
- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- NOVAPLUS V20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685285Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685280Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page