MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	2081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoesthesia (2352)
Date of Event	08/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please sign and return the attached form and provide your surgeon¿s name and contact information.
Event or Problem Description
It was reported by the patient that she had a c-section on (b)(6) 2019 and an absorbable hemostat was used to stop the bleeding over her uterus and bladder.Since her procedure she does not have the urge to urinate.Her physician told her that none of the nerves were cut.Patient indicated that she can urinate but there is no urge.She can however feel when she does urinate.She also has issues dripping since the c-section.That wasn't a problem before.She has discussed the issue with her o.B.To determine if the symptoms she is having is common after using this product.No additional information was provided.Additional information was requested.

• Brand Name: SURGICEL SNOW 1INX2IN(2.5CMX5.1CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9354272
• Report Number: 2210968-2019-90168
• Device Sequence Number: 2158427
• Product Code: LMG
• UDI-Device Identifier: 10705031063587
• UDI-Public: 10705031063587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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 Catalogue Number: 2081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention