MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO MULTI-PURPOSE SKULL CLAMP (SET); DORO® MULTI-PURPOSE SKULL CLAMP (SET)

Model Number	3020-00
Health Effect - Clinical Codes	Skin Discoloration (2074); Injury (2348)
Date of Event	04/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible as the device was not returned.We suspect that the skin damage was caused due to improper positioning of the patients head.
Event or Problem Description
Quality management was contacted on 15th of july 2020 from customer.Customer stated a pressure injury and pink skin relating to the use of a doro® multi-purpose skull clamp (set).

• Brand Name: DORO MULTI-PURPOSE SKULL CLAMP (SET)
• Common Device Name: DORO® MULTI-PURPOSE SKULL CLAMP (SET)
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 10452777
• Report Number: 3003923584-2020-00017
• Device Sequence Number: 19725085
• Product Code: HBL
• UDI-Device Identifier: 04250435501573
• UDI-Public: 04250435501573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 3020-00
• Device Catalogue Number: 3020-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR