MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for VICRYL POLYGLACTIN 910 SUTURE FRJV442 manufactured by Ethicon Inc..
[186814623]
(b)(4). A manufacturing record evaluation was performed for the finished device jv442; mmbbdrr0 number, and no non-conformances related to the reported complaint condition were identified. Additional information was requested and the following was obtained: was medication prescribed for the superficial site infection? If yes, please describe. Antibiotics were prescribed. Cannot remember the name of the medicine. Date and name of index surgical procedure - cannot associate a procedure name to a specific complaint. For these 4 complaints, it can be a ptosis cure, a breast implant or a thigh lifting. On what tissue was the suture used? The device was used on skin and subcutaneous tissue. What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? The tissue was normal. What were current symptoms following the index surgical procedure? Onset date? The healing was normal during the 3 first weeks, the infection occurred after then. Were cultures performed? If yes, results? Did not know if culture was performed. What is the patient? S current status? The patients go well. 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. The patient demographic info: age, gender, weight, bmi at the time of index procedure? The diagnosis and indication for the index surgical procedure? Were there any changes to cleansing regimens preoperatively? What were current symptoms following the index surgical procedure? Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? Did the patient receive any prophylactic antibiotics pre-, intra-op? Did the patient receive oral or topical antibiotics? Were cultures performed? Results? Other relevant patient history/concomitant medications. What is physician? S opinion as to the etiology of or contributing factors to this event? What is the patient? S status? Note: events reported via mw 2210968-2020-02385, 2210968-2020-02386, 2210968-2020-02387.
Patient Sequence No: 1, Text Type: N, H10
[186814624]
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used. The procedure was reported to be ptosis cure, breast implant or thigh lift and device was used on skin and subcutaneous tissues. The patient healing was normal during the first three weeks post-op. The patient experienced a superficial infection and delay in healing three weeks post-op and was treated by antibiotic therapy. The patient is reported as well. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02389 |
| MDR Report Key | 9885400 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-GMBH |
| Manufacturer Street | ROBERT-KOCH STRASSE 1 |
| Manufacturer City | NORDERSTEDT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICRYL POLYGLACTIN 910 SUTURE |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID |
| Product Code | GAM |
| Date Received | 2020-03-26 |
| Catalog Number | FRJV442 |
| Lot Number | MMBBDRRO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |