MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP; DORO® QR3 MULTI PURPOSE SKULL CLAMP

Model Number	3020-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ecchymosis (1818)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device reportedly involved in the incident has not been returned to the manufacturer for investigation.Therefore no inspection can be performed on the device itself.Based on the information provided by the reporting customer, only assumptions can be made regarding the possible cause(s) of the pressure sores described.From our experience, there are a few factors that affect the risk of positioning injuries.Pediatric patients especially have an increased risk for pressure wounds, compared to otherwise healthy adults, as their skin is more sensitive.Another decisive factor is the pressure applied.Care is to be taken that the patient is not positioned on very sensitive areas like eyes or nose.Also, when using lateral pads on the multi-purpose skull clamp, the pressure should be limited to the necessary minimum for stabilization.The risk for injuries certainly also depends on the duration the pressure is applied.The reporting customer stated that the pediatric patient was operated in dorsal position for 5 to 6 hours.Yet another factor that can increase the risk for pressure is humidity, or liquids.Some users use a towel or gauze between the gel and the patient to allow breathing of the skin and absorb any liquids.The customer is informed of our experience-based recommendations.If the product is received, an investigation will be carried out and presented in a follow-up report.
Event or Problem Description
Customer informed us on (b)(6) that one of our products was invovled in a case, in which the treated patient sustained a bedsore/ an eschar on the back of the skull.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® QR3 MULTI PURPOSE SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 20350522
• Report Number: 3003923584-2024-00031
• Device Sequence Number: 18193155
• Product Code: HBL
• UDI-Device Identifier: 04250435501689
• UDI-Public: 04250435501689
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3020-50
• Device Catalogue Number: 3020-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown