MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RH WIDE SKIN STPLR; REMOVABLE (SKIN)

Catalog Number	PRW35
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Month and day unknown.Only year (2018) is known.Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that "hole noted in packaging before opening product." there were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: the analysis results found that a prw35 device was returned inside its package unopened.Upon visual inspection, it was observed that the blister from the packaging was damaged; besides that it was observed that the packaging appeared to have been hit by a hard surface causing a sterility breach.Due to the damage found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Common Device Name: REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8245099
• Report Number: 3005075853-2019-15898
• Device Sequence Number: 1607504
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: 10705036013020
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K833357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: PRW35
• Device Lot Number: R40X2M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1