MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-22 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[139578461]
(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.
Patient Sequence No: 1, Text Type: N, H10
[139578462]
It was reported by the patient that the underwent a foot surgery on (b)(6)2019 and suture was used. Following the procedure, the patient? S skin got supersensitive and a little bit red. The patient had first post-op appointment on (b)(6)2019. The physician removed the dressings and some stitches and covered the patient? S foot with a large band aid and patient was instructed to start physical therapy in about a week. On (b)(6)2019, the patient had their first physical therapy appointment. The therapist looked at the patient? S foot and patient explained that the skin around the incisions had been extremely sensitive and was painful to even lightly touch. The physical therapist explained that the dissolving stitches hadn't completely dissolved and that she would need to remove them. She began touching the stitches with tweezers, lifting the edges lightly to see where to start. The patient reported that this was so painful they got nauseous. The physical therapist was only able to remove some of the stitches and the rest of the stitches were removed at the next appointment with the almost the same level of pain while extracting them. The patient had final follow-up with physician on (b)(6)2019. The patient reported that the physician opined the patient had the symptoms of being hypersensitive to topical skin adhesive. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-79611 |
| MDR Report Key | 8444374 |
| Report Source | CONSUMER |
| Date Received | 2019-03-22 |
| Date of Report | 2019-02-23 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-06-05 |
| Date Added to Maude | 2019-03-22 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, ABSORBABLE |
| Product Code | GAK |
| Date Received | 2019-03-22 |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |