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 2020-03-13 for GYNECARE INTERCEED 5INX6IN 4350XL manufactured by Ethicon Inc..
[183289704]
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Additional information was requested, and the following was obtained: "date and indication of initial surgical procedure? No further information is available. Were there any intra-op complications? No further information is available. Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? No further information is available. Other relevant patient comorbidities/concomitant medications? No further information is available. What medical intervention was given for the pain management? Results? Puncture suction was done, then, brown material was suctioned. After puncture suction was done twice, the patient recovered. Onset date of accumulation from the initial surgery? No further information is available. Diagnostic confirmation of accumulation? No further information is available. Nature and character of accumulation? No further information is available. Please clarify what does? Accumulation of something? Mean? No further information is available. Were there any culture tests performed? Results? No further information is available. What is physician? S opinion as to the etiology of or contributing factors to this event? The doctor commented, ""there may have been an infection. "" does the surgeon believe that interceed causes this? Accumulation of something?? No further information is available. What is the patient's current status? After puncture suction was done twice, the patient recovered. Product lot number? The lot number is unknown. The patient demographic info: age, gender, weight, bmi at the time of index procedure? "" no further information is available. No further information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[183289705]
It was reported that the patient underwent an unknown digestive surgery on unknown date and the absorbable adhesive barrier was used. A month after the surgery, the patient complained of abdominal pain. It was also reported that accumulation of something was observed directly under the abdominal wall. Puncture suction was done, then, brown material was suctioned. After puncture suction was done twice, the patient recovered. The doctor opined that there may have been an infection. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02014 |
| MDR Report Key | 9827891 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-13 |
| 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.-SAN LORENZO PR |
| Manufacturer Street | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO PR |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE INTERCEED 5INX6IN |
| Generic Name | BARRIER, ABSORBABLE, ADHESION |
| Product Code | MCN |
| Date Received | 2020-03-13 |
| Model Number | 4350XL |
| Catalog Number | 4350XL |
| 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 | 2020-03-13 |