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Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned 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.Additional information was requested, and the following was obtained: 1.Source of information: obtained from the initial reporter on dd mmm yyyy or provided from knowledge as you were present in the case? obtained from dr jacqueline.2.It is noted that patient experienced irritation after suture was used.I.Please clarify if there was life-threatening illness or injury, no ii.Please clarify if there was any permanent impairment of a body function or permanent damage to a body structure as a result, no iii.Please clarify if there was any medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.Yes.Dr tan removed the sutures from the patient 2.Please note that a ¿yes¿ or ¿no¿ answer is required for each of the above 3 points and elaborate if answer is ¿yes¿ to any of the 3 points.3.Please provide lot/batch number of affected device the lot number of mcp490g suture used on the patient is unknown.4.Course of action/remedial action and was any surgical/medical intervention performed? dr tan removed the sutures from patient, provided wound care advice, and applied dressing.Upon clarification, the patient did not experience infection.However, as a precautionary measure, dr tan still administered antibiotics.5.Patient outcome and current patient status patient is currently well.6.Is photo available of patient reaction? yes (please see attached).7.Name of surgery release (for de quervain's syndrome).8.What was the procedure date? operated by dr (b)(6) on the following dates: patient 2: (b)(6) 2024.9.What date /day post op was the reaction noted? noted by dr (b)(6) on the following dates: patient 2: (b)(6) 2024.1.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 1.Private & confidential 2.Date and name of index surgical procedure? 1.Release (for de quervain¿s syndrome).3.Patient 2: (b)(6) 2024 3.The diagnosis and indication for the index surgical procedure? 1.Release for de quervain¿s syndrome.4.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? 1.Open (de quervain¿s syndrome) 5.On what tissue was the suture used? subcuticular skin 6.What was the tissue condition (normal, thin, calcified, fragile, diseased)? normal 7.How was the suture placed (interrupted or continuous)? continuous 8.How was the suture originally tied (multiple knots, square knot, etc.)? aberdeen knots 9.Was the suture expected to be absorbed by 3 weeks? absorption for monocryl plus suture is essentially complete by 91-119 days.1.Yes.Dr tan is aware of the usual absorption time.2.Patients¿ discomfort were noted 1-3 months after post-op, so sufficient time was provided to allow the sutures to be absorbed.10.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).1.Confirmed with dr tan that no infection was present.2.However, the skin on the patients¿ wrists at the suture sites appear raised and irritated.3.Patients reported discomfort as they could feel the sutures still present under their skin, hence dr tan removed the remaining sutures from the sites.11.Please provide the onset date/time of infection from the initial surgical procedure.1.No infection was present.12.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? 1.No.13.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? 1.Patients received induction dose of antibiotics.2.Post-op, the patient received antibiotics.14.Were cultures performed? if so, please provide the results.1.Nil.No infection.15.How much and what type of drainage is present in this wound? 1.No drainage.16.Please describe any medical intervention performed including medication name and results.1.Removed the sutures from the patient, provided wound care advice, and applied dressing.3.17.Were any pre-op cleansing procedures changed recently? if yes, please describe.No change in pre-op cleansing.Dr tan uses cetrimide and chlorhexidine.18.Does the patient have a known allergic history to any medical devices, food and/or medication? no known allergies.19.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no.20.What symptoms did the patient experience following the index surgical procedure? onset date? patient experienced discomfort as they could feel retained sutures under their skin.21.Other relevant patient history/concomitant medications? no.22.What is the physician¿s opinion as to the etiology of or contributing factors to this event? 1.Dr (b)(6) has been using monocryl 5/0 and the same suturing technique for many years.2.The cause of this event cannot be a sterility issue because her patients have no issues post-op.The issues only arise 1-3 months later, when patient report discomfort and the skin at their suture skins is raised, indicating remnant sutures undissolved in their skin.3.Such an incident has not happened before.Hence, the underlying cause is likely to do with this particular batch of monocryl 5/0 sutures used on those 3 patients, such as their absorbability/dissolvability.23.What is the patient's current status? patient is okay.24.Lot number? unknown.Hence, next course of action is to exchange out the remaining mcp490g sutures at (b)(6) hospital, which is the only hospital where these incidents involving monocryl 5/0 sutures have occurred.Dr raised that as a hand surgeon, she is confident that the recent incidents are not a result of her suturing technique.
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Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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