MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 5-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z493G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Local Reaction (2035)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.(b)(4).If the device or further details are received at a later date a supplemental medwatch will be sent.Investigation summary: upon visual inspection of the image received to ethicon inc for evaluation.It was observed a foil packet of product code z493.Based on the set of photos review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of our quality process, the manufacturing records for this lot serial number were reviewed and manufacturing standards were met prior to the release of this lot.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.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 provide your surgeon¿s name, contact information and sign release of medical information form attached.Note: event reported in 2210968-2022-01405.
Event or Problem Description
It was reported by the patient that she underwent a hand procedure in (b)(6) 2020 and suture was used for closure.Several weeks after the procedure, the patient started breaking out and has had frequent degranulation's "flare ups" of her mast cell disease since then which put her into anaphylactic shock.With the suture, started breaking out around the site with localized mast cell reaction and problems cascading from that.Additional information was requested.

• Brand Name: PDSII CLR 18IN 5-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13636820
• Report Number: 2210968-2022-01404
• Device Sequence Number: 12021697
• Product Code: NEW
• UDI-Device Identifier: 10705031061156
• UDI-Public: 10705031061156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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 Expiration Date: 06/30/2026
• Device Model Number: Z493G
• Device Catalogue Number: Z493G
• Device Lot Number: RHMCLB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female