MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL MONOCRYL+; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B109
Health Effect - Clinical Code	Erythema (1840)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: what was the date of the initial procedure? [n/a.] what tissue was the stratafix spiral suture used on? [subcuticular.] when did the erythema and redness start (what post op day)? [n/a.] were cultures taken of the wound? [no.] what are results of culture? [n/a.] what medical intervention was performed for the post op erythema and redness? [antibiotics.] what suture did the surgeon use prior to the use of stratafix spiral? [n/a.] what is the surgeon¿s opinion of the causative relationship between the suture and wound redness? [surgeon suspected the redness is due to long absorption period of the suture (91-119 days).] what is the current condition of the patient? [patient had healed.].
Event or Problem Description
It was reported that a patient underwent an unknown procedure for trauma on unknown date (b)(6) 2018 and barbed suture was used.One week post procedure, the patient experienced erythematous condition and redness.The patient was treated with antibiotics.The patient is reported as healed.Additional information has been requested.

• Brand Name: STRATAFIX SPIRAL MONOCRYL+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7696176
• Report Number: 2210968-2018-74459
• Device Sequence Number: 904356
• Product Code: GAM
• UDI-Device Identifier: 10705031236608
• UDI-Public: 10705031236608
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: 09/30/2018
• Device Catalogue Number: SXMP1B109
• Device Lot Number: KLH659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/17/2018
• 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: Required Intervention
• Patient Age: 28 YR