MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-02-13 for SUPER QA+ #2 PAN CP-2 *EA 212135 manufactured by Depuy Mitek Llc Us.
[188656474]
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 expiration date is unknown. This is report 1 of 4.
Patient Sequence No: 1, Text Type: N, H10
[188656475]
It was reported by the affiliate by customer's email that during an unknown procedure the suture material of the super qa+ #2 pan cp-2 ea torn despite the experienced pulling and knowledge of the implant. No patient consequence and no surgical delay was reported. Additional information: adequate supply of the knee extensor was not possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00552 |
| MDR Report Key | 9705913 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-02-13 |
| 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 | 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 | SUPER QA+ #2 PAN CP-2 *EA |
| Generic Name | SOFT-TISSUE ANCHOR, BIOABSORBABLE |
| Product Code | JDR |
| Date Received | 2020-02-13 |
| Model Number | 212135 |
| Catalog Number | 212135 |
| Lot Number | 5L80121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |