Karl Schumacher PLUG RCWP0001Recalls & reported problems
Karl Schumacher Dental Instrument CO., Inc. · Resorbable Collagen Dental Wound Dressing · Class U
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 00842517100060), received between Aug 25, 2023 and Aug 25, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LIMITED INFORMATION REGARDING EVENT WAS PROVIDED. DURING INITIAL INTAKE, CUSTOMER REPORTED PATIENT EXPERIENCED ALLERGIC REACTION. IT WAS LATER CLARIFIED PATIENT HAD SURGICAL EXTRACTION OF TOOTH #30 ON (B)(6) 2023. MULTIPLE PRODUCTS WERE USED DURING THE PROCEDURE, INCLUDING THE KARL SCHUMACHER PLUG AND OTHER, UNSPECIFIED PRODUCTS. AT THE FOLLOW-UP VISIT ON (B)(6) 2023 THE PATIENT HAD A SWOLLEN CHEEK. A SECOND FOLLOW-UP VISIT ON (B)(6) 2023 WAS CONDUCTED ONCE PATIENT STOPPED THE STEROIDS; CHEEK BECAME "SEVERELY SWOLLEN." CUSTOMER STATED PATIENT WAS SENT TO AN ORAL SURGERY SPECIALIST FOR ADDITIONAL FOLLOW-UP. THE PATIENT WAS ALSO ADVISED IF THE ALLERGIC REACTION CONTINUED TO GO TO THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES, INCLUDING: THE RESULTS FROM THE ORAL SURGEON FOLLOW-UP, THE OTHER PRODUCTS USED IN THE INITIAL PROCEDURE, THE TYPE AND DOSAGE OF STEROIDS PRESCRIBED TO THE PATIENT AFTER THE INITIAL PROCEDURE, AND THE CURRENT PATIENT STATUS. CUSTOMER WAS UNABLE TO CONFIRM THE REQUESTED INFORMATION. THE CUSTOMER DID HOWEVER CLARIFY IT IS BELIEVED THE PATIENT'S ALLERGIC REACTION WAS NOT CAUSED BY THE KARL SCHUMACHER PLUG AND THE PATIENT MAY HAVE HAD AN INFECTIO
Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema
MAUDE report 17627040 ↗
Other Dressing, Wound, Collagen devices
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- Cytal® WSM0505Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-880Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-440Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-125Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Karl Schumacher TAPE RCWT0001Karl Schumacher Dental Instrument CO., Inc. · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 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.
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