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 2020-03-16 for TRUESPAN 0 DEGREE PEEK 228150 manufactured by Medos International Sàrl.
[188649045]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi:(b)(4) incomplete. The lot number is unknown.
Patient Sequence No: 1, Text Type: N, H10
[188649046]
It was reported by the sales rep via complaint submission tool that during a unknown procedure the truespan 0 degree peek didn? T hold and the surgeon ruined the meniscus. The was no surgical delay provided. No additional information was provided. Additional information received from the affiliate reported it was unknown if a surgical delay or patient consequences occurred during an acl or kas repair. It was reported the case was completed with an alternative device and surgical intervention is not planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00869 |
| MDR Report Key | 9837826 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-27 |
| Date Added to Maude | 2020-03-16 |
| 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 | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT MITEK |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUESPAN 0 DEGREE PEEK |
| Generic Name | SOFT-TISSUE ANCHOR, BIOABSORBABLE |
| Product Code | MBI |
| Date Received | 2020-03-16 |
| Model Number | 228150 |
| Catalog Number | 228150 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |